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Annexure I
(Reference File No.: MED-16014(12)/1/2024-eoffice)
CATEGORIES OF MEDICAL DEVICES FOR RISK-BASED CLASSIFICATION
S. No. Categories of Medical Devices
1 Interventional Radiology
2 Radiotherapy
3 Oncology
4 Class A (non-sterile and non-measuring) medical devices
Note: All concerned associations/stakeholders are requested to forward their
comments by filling the Google form at https://docs.google.com/forms/d/1e-
FFEU6wVU9nxgE-B40lJfeFdaMHxO_Y1jxUiQSq2sw/edit?pli=1 within 30 days from
the date of publication of this draft.Name of Category:
Interventional Radiology
Total No. of Devices:
186Category: Interventional Radiology
S. Device name Intended use Risk
No. Classification
1 Angiographic x- An angiographic x-ray system is a device Class C
ray system intended for radiologic visualization of the
heart, blood vessels, or lymphatic system
during or after injection of a contrast medium.
2 Angiography A battery-powered assembly of devices Class C
contrast medium designed to inject contrast media through a
injection system, small catheter and into the vascular system
battery-powered for angiographic procedures (e.g.,
examination of the coronary and renal
arteries, and great vessels and vasculature of
the heart, brain, abdominal organs, and
extremities).
3 Angiography An assembly of devices designed to inject Class C
contrast medium contrast media through a small catheter and
injection system, into the vascular system for angiographic
line-powered, procedures (e.g., examination of the coronary
mobile/stationary and renal arteries, and great vessels and
vasculature of the heart, brain, abdominal
organs, and extremities). It consists of mains
electricity (AC-powered) electromechanical
injectors (electric motor connected to a
jackscrew that moves a syringe piston) with
syringes capable of delivering media with the
pressure, flow range, and volume required for
angiographic studies, and may be stationary
or mobile (e.g., on a wheeled pedestal).
Some types can synchronize media delivery
with the electrocardiographic cycle and/or the
x-ray generator.
4 Automatic An automatic radiographic film processor is a Class C
radiographic film device intended to be used to develop, fix,
processor wash, and dry automatically and continuously
film exposed for medical purposes.
5 Automatic- A standard, diagnostic x-ray beam-limiting Class B
aperture-control and shaping device that includes an
diagnostic x-ray automatically controlled motorized shutter
system mechanism. It is designed to adjust the
collimator shutters so that the x-ray beam shape
matches the size of the film cassette in the
holder and is attached to the beam exit port
of a diagnostic x-ray system tube housing
assembly. It is used to limit the effects of
scattered radiation on image quality and to
provide patient protection by eliminating
exposure to non-target body areas.
6 Axial length An ophthalmic device that uses ultrasound Class B
measuring technology to measure axial length of the eye
ultrasound (distance along the axis of the eye between
system the anterior corneal surface and the anterior
retinal surface).S. Device name Intended use Risk
No. Classification
7 Basic diagnostic A non-powered table that is a component of a Class B
x-ray system basic diagnostic x-ray system designed to
table, non- position and support a patient during a variety
powered of routine/planar or speciality diagnostic
procedures requiring the use of a diagnostic
x-ray system; it is not a planar tomography
nor computed tomography (CT) table. It is not
intended for use during interventional
radiology/surgery.
8 Basic diagnostic A powered/programmable table that is a Class B
x-ray system component of a basic diagnostic x-ray system
table, powered designed to position and support a patient
during a variety of routine/planar or speciality
diagnostic procedures requiring the use of a
diagnostic x-ray system; it is not a planar
tomography nor computed tomography (CT)
table. It is not intended for use during
interventional radiology/surgery.
9 Basic/General- An assembly of devices that comprise an Class C
purpose analogue general-purpose mobile diagnostic
diagnostic x-ray x-ray system used in a variety of routine x-ray
system, imaging applications. It is typically an x-ray
mobile/stationary film based system using analogue or
/portable analogue-to-digital techniques for image
capture and display. It is commonly used for
bedside imaging and for interventional and
intraoperative imaging.
10 Bladder An ultrasound imaging transducer assembly Class B
ultrasound specifically designed to be positioned within
imaging the bladder either manually or under
transducer endoscopic guidance that steers, focuses,
and detects the ultrasound beam and
resulting echoes either mechanically or
electronically.
11 Bladder volume An assembly of portable, battery-powered Class B
ultrasound devices designed for the extracorporeal
imaging system ultrasound measurement of the male or
female urinary bladder volume. It typically
consists of an electronic measuring and
imaging display unit with a connected
ultrasound transducer which together
reproduce digitized data of the bladder,
typically bladder volume and post-void
residual (PVR), and images. It will generate
ultrasound pulses, direct them to the target
area, detect the ultrasound echoes, and
process the resulting information to produce
and display static or dynamic three-
dimensional (3-D) data/images. It is used in
the diagnosis of urinary retention and
postoperative urinary retention (POUR).S. Device name Intended use Risk
No. Classification
12 Blood flowmeter A flexible tube intended to be inserted into Class C
catheter, Doppler the lumen of a blood vessel to determine
blood-flow velocity by measuring the
ultrasonic frequency shift between
transmitted and reflected signals (Doppler
principle).
13 Body-orifice A sheath intended to be used as a physical Class B
ultrasound barrier for protection against the effects of
imaging environmental exposure (e.g., body fluids,
transducer cover gliding creams) and/or to maintain the
required hygienic level of an ultrasound
imaging system transducer (probe) used in
natural body orifices (e.g., vagina, rectum,
oesophagus) during an ultrasound
examination; it has no additional functionality.
14 Body-orifice A sheath containing an extraluminal Class B
ultrasound pocket/balloon portion intended to cover an
imaging ultrasound imaging system transducer
transducer (probe) used in natural body orifices (e.g.,
cover, image- vagina, rectum), to both protect the
enhancement transducer and improve image quality. The
balloon portion is intended to, when filled with
an aqueous solution (e.g., saline), displace
air and provide an adjustable interface
between the transducer and the anatomy of
interest (e.g., prostate) to improve imaging.
15 Bone A bone densitometer is a device intended for Class C
densitometer medical purposes to measure bone density
and mineral content by x-ray or gamma ray
transmission measurements through the
bone and adjacent tissues.
16 Bone sonometer A bone sonometer is a device that transmits Class B
ultrasound energy into the human body to
measure acoustic properties of bone that
indicate overall bone health and fracture risk.
17 Cardiovascular A magnetic resonance (MR) diagnostic Class C
MRI system, imaging device specifically designed to
Permanent visualize the cardiovascular system. The
magnet device uses a permanent magnet, and can
be stationary, mobile, or portable. The device
is equipped with a patient support bed
specifically designed to control the
positioning of the patient's body, to optimize
visualization of the cardiovascular system at
rest and during exercise stress tests, or
during interventions.S. Device name Intended use Risk
No. Classification
18 Cardiovascular A magnetic resonance (MR) diagnostic Class C
MRI system, imaging device specifically designed to
resistive magnet visualize the cardiovascular system. The
device uses a resistive magnet and is
equipped with a patient support bed
specifically designed to control the
positioning of the patient's body, to optimize
visualization of the cardiovascular system at
rest and during exercise stress tests, or
during interventions.
19 Cardiovascular A magnetic resonance (MR) diagnostic Class C
MRI system, imaging device specifically designed to
Superconducting visualize the cardiovascular system. The
magnet device uses a superconducting magnet, and
can be stationary, mobile, or portable. The
device is typically equipped with a patient
support bed specifically designed to control
the positioning of the patient's body, to
optimize visualization of the cardiovascular
system at rest and during exercise stress
tests, or during interventions.
20 Cardiovascular An assembly of mains electricity (AC- Class C
ultrasound powered) devices designed for
imaging system extracorporeal and/or intracorporeal
(endosonography or endoscopic) imaging
procedures involving the heart and blood
vessels. Included are software packages that
support a variety of static or real-time cardiac
specific imaging applications used to
diagnose anatomical defects of the heart,
determine blood flow characteristics and
functional/anatomical problems associated
with myocardial infarction. It is used to
generate ultrasound pulses, direct them to a
target area, detect the echoes, and process
the resulting information to produce and
display static or dynamic two or three-
dimensional (3-D) images. May be used in
intraoperative surgical planning.
21 Cephalometric A sensor for a digital X-ray image processing Class C
digital X-ray system combined with a diagnostic X-ray
sensor system designed for visualization and size
measurement of the human head (skull)
using radiation. The sensor consists of the
charge coupled devices (CCDs) and contains
a sensor driving circuit and signal processing
circuit
22 Cine or spot A cine or spot fluorographic x-ray camera is a Class C
fluorographic x- device intended to photograph diagnostic
ray camera images produced by x-rays with an
imageintensifierS. Device name Intended use Risk
No. Classification
23 Computed A device/device assembly designed to be Class B
radiography used with an analogue x-ray system to
digital imaging capture radiographic images and then
scanner generate digital x-ray images from them as
part of a two-step process (computed
radiography) for image viewing, storage, or
hard-copy printing; it is not dedicated to
dental use. It consists of an image
reader/scanner and may also include an
exposure unit with imaging receptor (e.g., a
cassette containing a plate), or additional
supportive hardware (e.g., a printer).
24 Computer A mainframe computer, a personal computer Class B
system for (PC) or a PC-based platform, and related
ultrasound hardware, software and operating system
imaging system software dedicated used for controlling and
monitoring performance of a diagnostic
ultrasound system and related image
processing, display and analytical functions.
25 Contrast medium An assembly of electromechanical devices Class B
conservation that controls the amount of contrast agent
system (Contrast supplied to the syringe/injector portion of the
management contrast medium injector system. It is
system) designed to optimise the use of injectible
contrast agents in order to prevent
unnecessary waste of contrast media during
and/or between patient procedures.
26 Contrast medium A collection of noninvasive devices designed Class B
injection system to conduct fluids between a contrast medium
administration injection system and a patient catheter for the
set delivery of a contrast medium and/or saline
solution to a patient undergoing a diagnostic
imaging procedure. It consists of tubing with
switches/valves and connectors to
syringes/fluid/contrast medium injection
system, and possibly a pressure transducer.
This is a disposable device.
27 Contrast medium A mains electricity (AC-powered) electronic Class C
injection system device that may be a component of a contrast
control unit medium injector system and designed to
initiate and terminate the operation of a
contrast medium injection procedure from a
remote location (e.g., the shielded operators
control room).S. Device name Intended use Risk
No. Classification
28 Contrast medium A collection of non-powered devices Class C
injection system designed to be used and interact with a
hand controller contrast medium injection system for the
kit administration of a contrast medium or saline
solution to a patient undergoing a diagnostic
imaging procedure. It consists of a high
pressure line, a high pressure stopcock, and
a hand-held manual controller used to stop
and start the contrast medium injection
system instantaneously.
29 Contrast medium A component of a contrast medium injection Class B
injection system system for the administration of a contrast
syringe medium or saline solution to a patient
undergoing a diagnostic imaging procedure.
It is primarily an exchangeable plunger-in-
barrel chamber for the medium/solution; the
movement of the plunger (piston) is
controlled by the contrast medium/solution
injector. This is a reusable device.
30 Coronary optical An assembly of optical and computer-based Class C
coherence devices that use a broad-bandwidth light
tomography beam for optical coherence tomography
system (OCT) to provide high-resolution images
(e.g., 5 to 40 microns) of the coronary
intravasculature. The system includes an
optical-imaging catheter which is connected
to the console for transmission of the images
from the intravascular site. The system may
be used during interventional cardiology,
radiology, or diagnostic angiography.
31 Coronary optical A sterile flexible tube with an extremely fine Class D
coherence working end that houses an optical fibre and
tomography imaging lens intended to be transcutaneously
system catheter introduced into the coronary vasculature to
perform coronary optical coherence
tomography (OCT). The proximal end of the
device connects to a coronary OCT console
for the transmission of high-resolution images
(e.g., 5 to 40 micron) of the coronary
intravasculature.
32 CT contrast An assembly of devices designed to inject Class C
medium injection contrast media through a small catheter and
system, into the vascular system for computed
stationary/mobile tomography (CT) procedures (e.g., spine,
head, gastrointestinal, or vascular diagnostic
procedures using CT scanning). The system
may synchronize media delivery with the x-
ray generator during CT scanning.S. Device name Intended use Risk
No. Classification
33 Dental computed A device/device assembly dedicated to dental Class B
radiography use and designed to be used with an
digital imaging analogue dental x-ray system to capture
scanner radiographic images and then generate
digital x-ray images from them as part of a
two-step process (computed radiography) for
image viewing, storage, or hard-copy printing.
It consists of an image reader/scanner and
may also include an exposure unit with
imaging receptor (e.g., a cassette containing
a plate), or additional supportive hardware
(e.g., a printer).
34 Dental digital X- A digital dental X-ray sensor used in the oral Class B
ray imaging cavity, in combination with a general-
sensor purpose dental X-ray imaging device. The
sensor consists of a CCD or other
components, and comprises a sensor drive
circuit and a signal processing circuit.
35 Dental x-ray film, A screen x-ray film specifically sized and Class B
screen designed for use with dental x-ray systems. It
is designed to be sensitive primarily to the
wavelengths of light emitted from an image
intensifying screen. May be used
endorally/extraorally.
36 Diagnostic A diagnostic ultrasonic transducer is a device Class B
ultrasonic made of a piezoelectric material that converts
transducer electrical signals into acoustic signals and
acoustic signals into electrical signals and
intended for use in diagnostic ultrasonic
medical devices.
37 Diagnostic x-ray A diagnostic x-ray beam-limiting device is a Class C
beam-limiting device such as a collimator, a cone, or an
device aperture intended to restrict the dimensions
of a diagnostic x-ray field by limiting the size
of the primary x-ray beam.
38 Diagnostic x-ray An assembly of medical devices designed to Class B
digital imaging convert an existing analogue x-ray system to
conversion digital (i.e., retrofit) through the acquisition
system and processing of digital images using
existing analogue x-ray system components.
As a system it consists of both: 1) a filmless
cassette-size digital detector (e.g., indirect
flat panel detector); and 2) additional
processing/viewing hardware [e.g., a central
processing unit (CPU) with integrated
software and a monitor]. It does not contain
the controls for the direct operation of an x-
ray imaging system.S. Device name Intended use Risk
No. Classification
39 Diagnostic x-ray A freestanding component of an x-ray-based Class B
digital imaging diagnostic digital imaging assembly intended
system to associate X-ray/CT/fluoroscopic images
workstation with patient and exam information, apply
images processing to facilitate diagnosis,
display the images, and output the resulting
image and exam data for further display,
distribution, or archiving. It may be intended
to be integrated as part of a radiology picture
archiving and communication system (PACS)
and does not have controls for direct
operation of the imaging system.
40 Diagnostic x-ray A diagnostic x-ray high voltage generator is a Class B
high voltage device that is intended to supply and control
generator the voltage and electrical energy provided to
a diagnostic x-ray tube for medical purposes.
41 Diagnostic x-ray A diagnostic x-ray tube housing assembly is Class B
tube housing an x-ray generating tube encased in a
assembly radiation-shielded housing that is intended for
diagnostic purposes.
42 Digital An assembly of devices intended to visualize Class C
angiographic x- and optimize the macroscopic or quantitative
ray system, evaluation of the anatomy and function of the
mobile/stationary blood and lymphatic systems in the heart,
/portable brain, or other organs. The device uses
digital technology for real-time image capture,
display, and manipulation, and typically may
have a radiographic function in addition to
fluoroscopic function.
43 Digital basic An assembly of devices that comprise a Class C
diagnostic x-ray digital general-purpose mobile diagnostic x-
system, ray system used in a variety of routine planar
mobile/portable/s x-ray imaging applications. It uses digital
tationary techniques for image capture, display and
manipulation. It is commonly used for
bedside imaging and for interventional and
intraoperative imaging.
44 Digital An x-ray system designed to generate and Class C
cephalometric x- control x-ray beams and to record the
ray system absorption patterns of x-rays passing through
a patient's head (skull). It is used for: 1)
radiographic visualization and measurement
of the dimensions of the human head, e.g.,
abnormal structures of the skull; 2)
orthodontic assessment of the relationship of
the teeth to the jaws and the jaws to the rest
of the facial skeleton; 3) assessment airway
and other soft tissue structures.S. Device name Intended use Risk
No. Classification
45 Digital general- A general-purpose diagnostic fluoroscopic x- Class C
purpose ray system that uses a C-arm and digital
fluoroscopic x- techniques for image capture, display and
ray system, manipulation and is designed to be used in a
mobile/portable/s variety of general-purpose applications
tationary requiring real-time fluoroscopic imaging
capabilities. It is also intended to optimize the
capability of users to visually and
quantitatively evaluate the anatomy and
physiological function of various targeted
body areas in real-time. It is frequently used
in conjunction with an ingested or injected x-
ray contrast medium. Images can be both
real-time and delayed formats.
46 Digital imaging A device that includes both a digital imaging Class B
cassette/storage cassette and a phosphor plate (also known
phosphor as screen) intended to receive radiation by a
screen, basic diagnostic x-ray system, to record a patient
diagnostic x-ray radiation pattern during a non-dental
(CR cassette) procedure. The device is then transferred,
with the cassette shielding the plate from
environmental light, to a computed
radiography (CR) scanner for insertion to
produce the digital image of the patient.
47 Digital intraoral A diagnostic dental x-ray system designed to Class C
dental x-ray generate and control x-ray beams. It records
system, the absorption pattern of x-ray beams used
mobile/portable/s for general-purpose, routine, dental
tationary/hand- radiography examinations involving the
held diagnosis and treatment (e.g., surgical or
interventional) of diseases of the teeth, jaw
and oral cavity structures. The data is either
from analogue-to-digital conversion
techniques imaging or by digital imaging.
48 Digital An assembly of devices specifically designed Class C
mammographic to be installed permanently and intended to
x-ray system, compress and image the breast. It is primarily
mobile/stationary used to optimize the capability of users to
/portable visually evaluate x-ray film images
representing the anatomy and function of
blood and lymphatic vessels within the
human breast. It may be used for breast
cancer screening and in conjunction with the
placement of biopsy markers and stereotactic
biopsy and lesion localization equipment
requiring x-ray guidance.S. Device name Intended use Risk
No. Classification
49 Digital A diagnostic digital dental x-ray system Class C
panoramic/tomo designed for permanent fixture in one
graphic dental x- location with an extraoral x-ray sensor and
ray system source intended to generate and control x-ray
(OPG) beams used in advanced dental imaging
applications involving the teeth, jaw, oral
cavity, sinus, and/or other maxillofacial
structures.
50 Digital uro- A diagnostic x-ray system with real-time Class C
gynaecological fluoroscopic capabilities specifically designed
fluoroscopic x- for use in urological and/or gynaecological
ray system surgical and interventional procedures
requiring real-time visualization of the pelvic
area.
51 Doppler blood- A portable or stationary ultrasonic device Class B
flow (invasive or noninvasive) that does not
measurement produce 2-dimensional or 3-dimensional
ultrasound images, and is intended to be used for
system determining various blood-flow related
parameters of the heart, artery, or vein. The
device is used to output audible data, or
display the Doppler shift as a function of time.
52 Electrostatic x- An electrostatic x-ray imaging system is a Class C
ray imaging device intended for medical purposes that
system uses an electrostatic field across a
semiconductive plate, a gas-filled chamber,
or other similar device to convert a pattern of
x- radiation into an electrostatic image and,
subsequently, into a visible image.
53 Emission An emission computed tomography system is Class C
computed a device intended to detect the location and
tomography distribution of gamma ray- and positron-
system emitting radionuclides in the body and
produce cross-sectional images through
computer reconstruction of the data
54 Extracorporeal A hand-held noninvasive component of an Class B
ultrasound ultrasound imaging assembly designed to be
imaging moved over the intact surface of a patient's
transducer, body, typically with a coupling gel, during a
hand-held variety of extracorporeal ultrasound imaging
(ultrasound procedures (non-dedicated). it converts
probe) electric voltages into ultrasound which it
transmits, detects resulting echoes, and
transmits a proportional signal/data to an
ultrasound system controller for image
processing and display. This is a reusable
device.
55 Extremity MRI A diagnostic magnetic resonance imaging Class B
system, (MRI) system employing permanent magnet
permanent technology specifically designed to image
magnet only the head and neck or limbs.S. Device name Intended use Risk
No. Classification
56 Extremity MRI A diagnostic magnetic resonance imaging Class B
system, (MRI) system employing superconducting
superconducting magnet technology specifically designed to
magnet image only the head and neck or limbs.
57 Flat panel A digital image acquisition system in which X- Class C
radiography and rays passed through a human body are
fluoroscopy captured by an X-ray flat panel detector, and
system digital output signals are supplied to an
image processing device to receive digital
images. If necessary, image processing
technology including gamma correction and
edge enhancement are applied to digital
images. Image data are either recorded on
the media, or output to a server or other
external devices for recording.
58 Flexible A flexible, ultrasound imaging transducer Class B
endoscopic assembly designed to be to be inserted
ultrasound through the working channel of an
imaging appropriate flexible endoscope and
transducer positioned within the gastrointestinal,
respiratory or urinary tract, (i.e., application is
not specific to any particular anatomy) to
transmit a signal/data to another device for
display. This is a reusable device.
59 Flexible An endoscope with a flexible inserted portion Class B
ultrasound intended for the visual examination and
bronchoscope treatment of the trachea, bronchi, and lungs.
It is inserted through the mouth or nose
during bronchoscopy.
60 Flexible An endoscope with a flexible inserted portion Class B
ultrasound intended for the visual examination and
colonoscope treatment of the entire colon [lower
gastrointestinal (GI) tract]. It is inserted
through the anus during colonoscopy.
61 Flexible An endoscope with a flexible inserted portion, Class B
ultrasound combined with an ultrasound probe, intended
duodenoscope for the visual examination and treatment of
the duodenum (the first part of the small
intestine). It is inserted into the body through
the mouth during duodenoscopy.
62 Flexible An endoscope with a flexible inserted portion, Class B
ultrasound combined with an ultrasound probe, intended
gastroduodenosc for the visual examination and treatment of
ope the upper gastrointestinal (GI) tract
[oesophagus, stomach, and duodenum (the
first part of the small intestine), including the
pancreas and the bile duct]. It is inserted into
the body through the mouth during
gastroduodenoscopy.S. Device name Intended use Risk
No. Classification
63 Flexible An endoscope with a flexible inserted portion, Class B
ultrasound combined with an ultrasound probe, intended
laparoscope for the visual examination, treatment, and
ultrasonic imaging of the
abdominal/retroperitoneal cavity and its
organs. It is inserted through an incision
made in the abdominal wall (routinely just
below the umbilicus) during laparoscopy.
64 Fluorescent A fluorescent scanner is a device intended to Class C
scanner measure the induced fluorescent radiation in
the body by exposing the body to certain x-
rays or low-energy gamma rays.
65 Foetal cardiac A mains electricity (AC-powered) device Class C
monitor designed to detect, measure, and display
foetal heart activity during the perinatal
period.
66 Foetal Doppler A portable, hand-held, battery-powered Class C
system device assembly consisting of a measuring
and display unit and an attached probe or
interchangeable probes designed to
noninvasively detect foetal heart beats using
ultrasound/Doppler technology. The heart
beats are typically conveyed audibly via the
measuring/display unit and attached probe
which is applied to the surface of the
pregnant woman's abdomen. The device aids
in determining foetal viability.
67 Full-body MRI A general-purpose magnetic resonance Class C
system, imaging (MRI) system designed to scan any
permanent targeted area of the body. It includes a
magnet permanent magnet assembly.
68 Full-body MRI A diagnostic general-purpose magnetic Class C
system, resistive resonance imaging (MRI) system designed to
magnet scan any targeted area of the body (full-body
imaging). It includes a resistive magnet
assembly.
69 Full-body MRI A diagnostic general-purpose magnetic Class C
system, resonance imaging (MRI) system designed to
superconducting scan any targeted area of the body (full-body
magnet imaging). This system includes a
superconducting magnet assembly.
70 General- A stationary or mobile (e.g., on wheels) Class B
purpose assembly of devices designed to collect,
ultrasound display, and analyse ultrasound images
imaging system during a variety of extracorporeal and/or
intracorporeal (endosonography or
endoscopic) ultrasound imaging procedures
(e.g., cardiac, OB/GYN, endoscopy, breast,
prostate, vascular, and intra-surgical
imaging).S. Device name Intended use Risk
No. Classification
71 General-purpose A general-purpose, analog diagnostic Class C
fluoroscopic x- fluoroscopic x-ray system designed to be
ray system, used in a variety of general-purpose
mobile/portable/s applications requiring real-time fluoroscopic
tationary imaging capabilities. It is frequently used in
conjunction with an ingested or injected x-ray
contrast medium. Images can be both real-
time and delayed formats.
72 Grid for MRI A grid used for position the puncture site etc. Class A
(needle guide when biopsying under the magnetic
positioner) resonance imaging (MRI) guide.
73 Hand-held A diagnostic dental x-ray system designed to Class C
intraoral dental generate and control x-ray beams. It records
x-ray system the absorption pattern of x-ray beams used
for general-purpose, routine, dental
radiography examinations involving the
diagnosis and treatment (e.g., surgical or
interventional) of diseases of the teeth, jaw
and oral cavity structures. The sensor is
placed in the mouth, the purpose being to
visualize a limited region in detail. The data is
either from analogue imaging and digitized
afterwards or by digital imaging.
74 Hand-held A battery-powered, hand-held device/device Class B
ultrasound assembly designed to be placed over the
imaging system, external body surface for collection, display,
body-surface and analysis of ultrasound information during
a variety of ultrasound imaging procedures
(i.e., non-dedicated); it may in addition be
intended to be used with a sterile cover for
intraoperative imaging. It consists of a flat- or
concave-lensed ultrasound transducer and
includes an integrated image processing
system; it may include an integrated display
or be intended to wirelessly transmit images
to an off-the-shelf device (e.g., smartphone,
tablet) with dedicated software installed. It is
not designed to be inserted into body orifices.
75 Hand-held A battery-powered, hand-held device/device Class B
ultrasound assembly designed to be inserted in
imaging system, vaginal/rectal cavity for collection, display,
rectal/vaginal and analysis of ultrasound information during
a variety of ultrasound imaging procedures
(i.e., non-dedicated); it may in addition be
intended to be used with a sterile cover for
intraoperative imaging.S. Device name Intended use Risk
No. Classification
76 Hand-held- An assembly of diagnostic devices Class B
detector nuclear comprising a hand-held, non-imaging system
medicine system designed primarily to detect, record, quantify
and analyse various radioactive emissions
(gamma, alpha, beta) of injected or ingested
radiopharmaceuticals, radiation emitting
devices, or other materials. It is frequently
used in the monitoring and detection of deep
vein thrombosis (DVT), in surgical
procedures requiring radionuclide localization
and in some radiolabeled monoclonal
antibody applications.
77 Head/extremity A magnetic resonance (MR) diagnostic Class C
imaging MRI imaging device specifically designed to
system visualize the head, neck, or limbs using a
resistive magnet.
78 Hepatic An assembly of mains electricity (AC- Class B
ultrasound powered) devices, which may include
elastography rechargeable batteries, designed to measure
system liver stiffness/ultrasonic attenuation of tissues
based on transient elastography for the
evaluation/diagnosis of hepatic disease (e.g.,
liver fibrosis/steatosis); it may additionally be
intended to measure spleen stiffness as an
adjunct evaluation. It is typically used during
diagnosis of chronic liver conditions such as
viral hepatits, alcoholic hepatitis, and biliary
disease, or for post-transplant evaluation.
79 Image- An image-intensified fluoroscopic x-ray Class C
intensified system is a device intended to visualize
fluoroscopic x- anatomical structures by converting a pattern
ray system of x-radiation into a visible image through
electronic amplification.
80 Indirect flat panel An electrically-powered, cassette-like device Class B
x-ray detector intended to be used as part of an x-ray
system to detect x-ray images following
exposure, and create a digital signal; it is not
dedicated to imaging of a specific anatomy. It
includes two types of transducing technology
(i.e., indirect): a scintillator [e.g. caesium
iodide (CsI)] screen converts x-ray energy
into light, followed by the conversion of light
into a digital signal by photodiode array. The
image data can be sent to an appropriate
processing unit through a wired or wireless
connection (e.g., Wi-Fi). It may be used in
place of a fixed detector in x-ray imaging
systems, e.g., as part of a digital imaging
conversion system.S. Device name Intended use Risk
No. Classification
81 Integrated An electrically-powered modular device Class C
ultrasound/electr intended for general medical examination
ocardiograph/ using ultrasound, electrocardiograph (ECG)
stethoscope unit and auscultation modalities, with a user
interface that enables synchronized data
display and recording. It consists of a multi-
purpose transducer designed for
transmitting/receiving ultrasound and sensing
sound signals, to which an ECG lead
assembly can be attached, and a connected
image display monitor (e.g., tablet) with
dedicated software; in addition to the
integrated electronic stethoscope, it may also
allow connection of a stethoscope headset
for the user to directly hear sounds.
82 Intracardiac A steerable, flexible tube with an ultrasonic Class D
ultrasound phased-array imaging transducer at its distal
imaging catheter, tip designed for intracardiac
steerable, single- echocardiography to enable intracardiac and
use possibly great vessel (e.g., pulmonary artery)
visualization for the assessment of cardiac
anatomy and physiology, and visualization of
other devices in the heart; it is not intended
for peripheral vascular or coronary artery
insertion/imaging. It is introduced
percutaneously, and includes controls to
allow it to be manoeuvred (steerable). It is
connected to a compatible ultrasound system
for transmission and display of the images.
This is a single-use device.
83 Intracorporal Intended to be used with a hand-held Class B
ultrasound ultrasound imaging system transducer to
transducer provide means to replace the position of a
contouring needle guide.
attachment
84 Intracorporeal An ultrasonic probe used temporarily in Class D
central nervous central nervous system surgery. It refers to a
system hand-held ultrasonic transducer assembly
ultrasound designed to be placed at the surgical site to
transducer/probe take local images during surgery. It includes
the configuration of various transducer
assemblies that consist of single or multiple
elements that convert voltage into an
ultrasonic beam. This category includes
ultrasonic transducers used for mode A,
mode B, mode M, Doppler, Color Doppler
(CD), and dual (combination image, Doppler
or color flow) scanning.S. Device name Intended use Risk
No. Classification
85 Intraoperative A sterile sheath intended to be used as a Class B
ultrasound physical barrier for protection against the
imaging effects of environmental exposure (e.g., body
transducer cover fluids, gels) and/or to maintain the required
hygienic level of an ultrasound imaging
system transducer (probe) used
intraoperatively, e.g., on internal organs,
during an ultrasound examination. This is a
single-use device.
86 Intraoral dental A diagnostic dental x-ray system designed to Class C
x-ray system, generate and control x-ray beams. It records
mobile/portable/s the absorption pattern of x-ray beams used
tationary/hand- for general-purpose, routine, dental
held radiography examinations involving the
diagnosis and treatment (e.g., surgical or
interventional) of diseases of the teeth, jaw
and oral cavity structures.
87 Intravascular A catheter and a guide wire used to observe Class D
optical a cross section of blood vessels using an
coherencetomog optical fiber by light. For instance, optical
raphy catheter coherence tomography visualizes internal
microscopic structure of the tissues without
physical invasion of the outer protective
layers. This utilizes the nature of light that
penetrates and is reflected at various
degrees according to the type of the tissue.
88 Intravascular A flexible, non-steerable tube with an Class C
ultrasound ultrasound imaging transducer enclosed in a
imaging catheter, fluid-resistant or waterproof acoustically- and
non-steerable electrically-insulated housing, designed for
insertion into the vascular system (i.e.,
peripheral vascular system, coronary artery)
by an operator; it is not intended for
intracardial insertion/imaging. Also known as
a vascular ultrasound transducer, it includes
either a single or an array of transducer
element(s) (piezoelectric, active, or crystal).
89 Invasive vascular A mains electricity (AC-powered) device Class C
ultrasound assembly designed to invasively locate and
system assess the extent of vascular flow restriction
(e.g., clots, stenosis, mechanical damage)
using ultrasound/Doppler/transit time
technology during procedures involving
vascular surgery. It may also provide
additional measurements (e.g., blood
pressure, vascular resistance). It consists of
a mobile (on wheels) control unit with
graphical user-interface, typically placed
outside the sterile field; and an attached,
reusable, sterilizable probe intended to be
used within the body (invasive) but not within
the lumen of the blood vessel.S. Device name Intended use Risk
No. Classification
90 Invasive vascular A hand-operated component of an invasive Class C
ultrasound vascular ultrasound system intended to be
system probe used perioperatively/intraoperatively to
measure the flow of blood in an isolated
blood vessel, by being applied to the outside
of the vessel, using ultrasonic/Doppler/transit
time technology. It may also be used for
cross-sectional visualization/imaging. This is
a reusable device.
91 Limited view field A diagnostic X-ray computed tomography Class C
X-ray computed (CT) system equipped with a gantry designed
tomography exclusively for taking images of the area from
system the head to the neck or the extremities. The
system is designed to have at least 1 fixed
circular arrangement of multiple X-ray tubes
and detectors, or designed to have an
assembly where single or multiple X-ray
tube(s) and detector(s) rotate around an axis
at high speed within the area that the gantry
can take images. Using this system, 2D or 3D
images are produced. In addition, spiral CT
and special radiography can be performed at
multiple angles set relative to the position of
the body.
92 Mammographic A powered/programmable x-ray Class B
biopsy x-ray mammography table with electronic positional
table, powered controls specifically designed to position and
support a patient during breast imaging
examinations usually in conjunction with
breast biopsy. It is made of radiolucent
materials with low x-ray attenuation
coefficients and typically has special
openings or attachments to facilitate breast
imaging.
93 Mammographic A magnetic resonance (MR) diagnostic Class C
MRI system, imaging device specifically designed for
Permanent breast imaging. The device uses a
magnet permanent magnet, and can be stationary,
mobile, or portable. The MR device for
mammography is typically equipped with a
dedicated patient support bed specifically for
the purpose of controlling the positioning of
the patient's body to optimize visualization of
the breast.
94 Mammographic A magnetic resonance (MR) diagnostic Class C
MRI system, imaging device specifically designed for
Resistive magnet breast imaging. The device uses a resistive
magnet, and can be stationary, mobile, or
portable. The MR device for mammography
is typically equipped with a dedicated patient
support bed for the purpose of controlling theS. Device name Intended use Risk
No. Classification
positioning of the patient's body to optimize
visualization of the breast.
95 Mammographic A magnetic resonance (MR) diagnostic Class C
MRI system, imaging device specifically designed for
Superconducting breast imaging. The device uses a
magnet superconducting magnet, and can be
stationary, mobile, or portable. The MRI
device for mammography is typically
equipped with a dedicated patient support
bed for the purpose of controlling the
positioning of the patient's body to optimize
visualization of the breast.
96 Mammographic An assembly of devices intended to be used Class B
stereotactic in conjunction with mammography to insert
biopsy system biopsy devices, typically designated needles,
into a breast in order to extract a biopsy of a
suspect tumour for diagnostic purposes. It
consists of a biopsy unit with needle guides,
needles, an examination table, and an
integral computer for communicating lesion
coordinates. It may be a standalone unit or a
unit that mounts onto an existing
mammographic unit.
97 Mammographic A mammographic x-ray system is a device Class C
x-ray system intended to be used to produce radiographs
(portable/mobile/ of the breast for diagnostic purposes. It may
stationary) be used intraoperatively.
98 Mammographic A device that can only fulfil its purpose when Class B
x-ray system used together with and enhance the function
stereotactic unit of a diagnostic mammographic x-ray system.
It is used to take two pictures of a breast from
two different angles. On the basis of this
stereoscopic picture set, it is possible to
determine the exact position of a lesion in the
breast and a cytological sample of this will be
taken. This device or technique may be built-
in to some diagnostic x-ray systems for
mammography.S. Device name Intended use Risk
No. Classification
99 Mammographic An assembly of devices specifically designed Class C
x-ray system, to be installed permanently and intended to
mobile/stationary compress and image the breast. It is primarily
/portable used to optimize the capability of users to
visually evaluate x-ray film images
representing the anatomy and function of
blood and lymphatic vessels within the
human breast. It may be used for breast
cancer screening and in conjunction with the
placement of biopsy markers and stereotactic
biopsy and lesion localization equipment
requiring x-ray guidance.
100 Manual contrast An assembly of devices designed for the Class B
medium injection manual-only injection of contrast media into
system the blood or lymphatic vessels of a patient for
a diagnostic imaging procedure; it enables
the operator to manually control the volume
and rate of contrast media administered
under pressure. The system typically consists
of a graduated injection syringe, a manifold
with multiple stopcocks, and a pressure
transducer system used by the operator to
monitor catheter-tip pressure.
101 Medical image Medical image analyzers, including Class B
analyzer/Medical computer-assisted/aided detection (CADe)
image devices for mammography breast cancer,
interpretive ultrasound breast lesions, radiograph lung
application nodules, and radiograph dental caries
software detection, are intended to identify, mark,
highlight, or in any other manner direct the
clinicians' attention to portions of a radiology
image that may reveal abnormalities during
interpretation of patient radiology images by
the clinicians. This device incorporates
pattern recognition and data analysis
capabilities and operates on previously
acquired medical images. This device is not
intended to replace the review by a qualified
radiologist, and is not intended to be used for
triage, or to recommend diagnosis.
102 Medical x-ray A screen x-ray film specifically designed for Class B
film, screen medical diagnostic imaging applications. It is
sensitive primarily to wavelengths of light
emitted from an image intensifying screen or
other visible light source. This film is not
limited to use with x-ray imaging systems but
can also be used in a variety of diagnostic
imaging modalities using image intensifier
technology or matrix formatters to output
images, e.g., nuclear medicine or ultrasound.S. Device name Intended use Risk
No. Classification
103 MR/CT roadmap A stand alone software that allows the Class C
(interpretive synchronization of live fluoroscopy images
software) with previously acquired MRA/CTA datasets.
This may be used as an aid in applications
such as image-guided surgeries, calibrating
the contrast medium doses, and needle
guidance.
104 MRI contrast An assembly of devices designed to inject Class C
medium injection contrast media through a small catheter and
system, into the vascular system for magnetic
mobile/stationary resonance imaging (MRI) procedures (e.g.,
spine, head, gastrointestinal, or vascular
diagnostic procedures using MRI). It may
interface with the MRI system or a monitoring
device to control timing of contrast injections;
it is made entirely of non-ferromagnetically
active materials for MRI compatiblity.
105 MRI image An interpretive software program intended to Class C
interpretive be used to analyse magnetic resonance
software imaging (MRI) data (e.g., prostate MRI) to
detect and localize suspected abnormalities
and sometimes provide results as clinically
relevant tags; it may additionally be intended
for three-dimensional (3-D) model creation
slice-based images (segmentation). It
typically utilizes artificial intelligence (AI) and
deep learning techniques, and may be
compatible with radiology information
systems, data formats, and medical imaging
software programs [e.g., picture archiving
and communication system (PACS), digital
imaging and communications in medicine
(DICOM) format].
106 MRI planner It is a stand alone software product intended Class C
(radiotherapy to enable a completely MRI-only workflow in
planning radiotherapy planning. It achieves this by
application analyzing a dedicated MR image and
software) generating a synthetic CT image that can
replace the conventional CT in the treatment
planning process. In addition, the software
may also performs automated contouring of
risk organs in certain anatomies.
107 MRI radio This radio frequency coil is intended to act as Class B
frequency coil a transmitter, receiver, or both a transmitter
and receiver of RF pulses necessary for
diagnostic magnetic resonance imaging
(MRI) procedures. It is intended to be used to
enhance image resolution by improving
signal to noise characteristics.S. Device name Intended use Risk
No. Classification
108 MRI system It is a standalone software application that is Class C
application intended to be used for viewing, post-
program processing and quantitative evaluation of
software magnetic resonance (MR) images for
applications such as quantitative
cardiovascular computed tomography (CT)
evaluation, determination of the triglyceride
fat fraction in magnetic resonance images of
the liver, multi slice and gradient echo image
analysis, etc. It does not drive MRI systems.
109 MRI system A physiological monitoring unit used as a Class B
synchronizer component of a diagnostic magnetic
resonance imaging (MRI) system, that
produces a signal which enables image
formation or data collection to be
synchronized with a specific measurable
physiological parameter, e.g., the beginning
of a patient's respiratory or cardiac cycle. It is
primarily used for the purpose of artifact
reduction or enhancement of signal-to-noise
ratios in various real-time or dynamic MRI
applications.
110 MRI system A powered/programmable table designed Class B
table, powered with electronic and/or software controls to
position and support a patient during
magnetic resonance imaging (MRI)
examinations. It is made with
ferromagnetically inactive materials and may
have a detachable table top, equipment
supports, physiological monitors, mattresses,
alarms and a patient positioning system
(PPS).
111 MRI system A standalone image-processing workstation Class B
workstation that is designed to be networked with one or
more magnetic resonance imaging (MRI)
systems. The workstation may have any type
of hardware, or any type of configuration. It is
not intended to control or directly manipulate
the diagnostic imaging device. The device
allows data transfer either on-line or off-line,
and is typically situated away from the MRI
operator console. It is intended to process
MRI images and provide valuable information
that allow decision making, evaluation or
diagnosis of the patient's pathologic
conditions.S. Device name Intended use Risk
No. Classification
112 MRI-patient A mobile assembly of devices designed for Class C
physiologic continuous assessment of several vital
monitoring physiologic parameters (e.g., ECG, blood
system pressure, heart rate, temperature, cardiac
output, apnoea, and respiratory/anaesthetic
gas concentrations) of infant to adult
intensive care patients during a magnetic
resonance imaging (MRI) procedure.
113 Multi-modality An assembly of diagnostic x-ray devices Class C
diagnostic x-ray intended to acquire, display and process
system (full body images from any part of the body (full-body)
CT/fluoroscopic incorporating the techniques of more than
x-ray system) one x-ray imaging modality, typically
including real-time fluoroscopy, two-
dimensional (2D) radiography, and computed
tomography (CT); it is not a single-modality
system.
114 Neurosurgical An individual software program or group of Class C
ultrasound programs, routines or algorithms that add
navigation specific image processing and/or analysis
system capabilities to a neurosurgical ultrasound
application (US) navigation system.
software
115 Neurosurgical A component of a neurosurgical ultrasound Class B
ultrasound (US) navigation system used to track the
navigation position of all the localizers/spatial markers
system optical during intraoperative imaging and to supply
tracking unit the US system with valid positional data. It
typically uses equidistant-placed cameras
using infrared (IR) light to measure the
position/placement of the reflective spheres
attached to the localizers or spatial marker
holders.
116 Nonfetal A nonfetal ultrasonic monitor is a device that Class B
ultrasonic projects a continuous high frequency sound
monitor wave into body tissue other than a fetus to
determine frequency changes (doppler shift)
in the reflected wave and is intended for use
in the investigation of nonfetal blood flow and
other nonfetal body tissues in motion.
117 Non-image- A non-image-intensified fluoroscopic x-ray Class C
intensified system is a device intended to be used to
fluoroscopic x- visualize anatomical structures by using a
ray system fluorescent screen to convert a pattern of X-
ray radiation into a visible image.S. Device name Intended use Risk
No. Classification
118 Noninvasive A hand-operated component of a vascular Class B
vascular ultrasound system intended to be used to
ultrasound probe measure the flow of blood noninvasively by
measuring flow in underlying vasculature
from the body surface pre-/post-operatively,
using ultrasonic/Doppler/transit time
technology. It may also be used for cross-
sectional visualization/imaging.
119 Noninvasive An electrically-powered device assembly Class C
vascular consisting of a control unit and an attached
ultrasound probe or interchangeable probes, designed to
system noninvasively locate and assess the extent of
vascular (venous and arterial) flow restriction
(e.g., clots, stenosis, mechanical damage) by
measuring blood flow rate using
ultrasound/Doppler/transit time technology. It
may also be used to detect the foetal
heartbeat.
120 Nuclear A nuclear electrocardiograph synchronizer is Class B
electrocardiogra a device intended for use in nuclear radiology
m to relate the time of image formation to the
synchronizer/Nu cardiac cycle during the production of
clear medicine dynamic cardiac images.
system
synchronizer
121 Nuclear A data processing system specifically Class C
medicine data dedicated for nuclear medicine. The system
processing is used for various types of filter processing,
system image display, clinical analysis, management
of image storage, etc. The system may have
a control system for directly operating a
diagnostic imaging unit. This system can
deliver or receive data online or offline, and
has a configuration that can provide functions
such as processing, manipulating, and
displaying a patient's images and information
collected with the nuclear medicine scan.
122 Nuclear A standalone imaging workstation specifically Class B
medicine system designed to create network connection with
workstation one or more nuclear imaging devices, such
as gamma camera, PET device, and SPECT
device. The workstation may have any type
of hardware, or any type of configuration. The
device may be regarded as a component of a
picture archiving and communication system
(PACS). It differs from an operator console in
that the workstation does not have controls
for the direct manipulation of the imaging
device.S. Device name Intended use Risk
No. Classification
123 Nuclear sealed A sealed radioisotope equipped dedicated for Class B
source for the correction of absorption of radiation from
absorption a diagnostic radioisotope by organs and
compensation tissues to improve quantitative capability of
diagnostic imaging of the nuclear imaging
system (PET or SPECT devices), thereby
improving accuracy of diagnosis.
124 Nuclear A nuclear tomography/medicine system is a Class C
tomography device intended to detect nuclear radiation in
system/nuclear the body and produce images of a specific
medicine system cross-sectional plane of the body by blurring
or eliminating detail from other planes.
125 Nuclear whole A nuclear whole body scanner is a device Class C
body scanner intended to measure and image the
distribution of radionuclides in the body by
means of a wide- aperture detector whose
position moves in one direction with respect
to the patient.
126 Oesophageal An ultrasound imaging transducer assembly Class B
ultrasound enclosed in a fluid-resistant, acoustically- and
imaging electrically-insulated housing, designed to be
transducer inserted and positioned in the oesophagus to
(oesophagal obtain ultrasound images of the heart and/or
endosonography to navigate devices requiring ultrasound
probe/transducer guidance and placement (e.g., endoscopy
) equipment or needle biopsy equipment). It is
composed of either a single transducer
element or an array of transducer elements,
i.e., piezoelectric element(s), active
element(s), or crystal(s), and associated
damping, backing, and matching layer
materials. It is reusable.
127 Ophthalmic An ultrasound imaging transducer that is a Class B
ultrasound hand-held device moved over the intact
imaging surface of a patient's eye during imaging
transducer applications involving the examination of the
lens. It may include single or multiple element
transducer assembly configurations that
convert electric voltages into an ultrasound
beam. This group of devices typically
includes ultrasound imaging transducers
used with A-mode scanning capabilities. This
is a reusable device.S. Device name Intended use Risk
No. Classification
128 Optical An OCT (optical coherence tomography) Class C
coherence diagnostic imaging system which
tomography diagnostically represents the images of tissue
(OCT) imaging characteristics and shapes of various sites
system (e.g., heart, blood vessel, abdomen, lung)
using near-infrared rays, without the need to
obtain tissues surgically. This system may or
may not contain a software package that
supports the taking of both still and real-time
images, and is used to diagnose anatomic
abnormalities in tissues and to examine
functional and anatomic features.
129 Optoacoustic/ultr A mobile assembly of electrically-powered Class B
asound imaging devices intended for imaging and analysis of
system soft-tissue and soft-tissue vasculature using
combined optoacoustic (photoacoustic) and
ultrasound (US) imaging. Pulsed near-
infrared laser light of various wavelengths is
emitted and the associated acoustic feedback
(photoacoustic effect) provides
complementary information regarding tissue
composition/functionality based on the
presence of endogenous chromophores,
such as haemoglobin; this photoacoustic data
can be overlaid on the associated US image.
130 Orthopaedic x- A device used in an orthopaedic clinical Class A
ray ruler setting to establish an accurate measurement
of length or size related to a bone structure
(i.e., length, thickness, or other aspects)
when this is being viewed by the surgeon
during fluoroscopy. It includes a series of
notches and holes that clearly show up on
the x-ray image demonstrating the distances
of the viewed bone.
131 Panoramic digital A sensor used in combination with a Class B
X-ray sensor diagnostic digital dental X-ray imaging device
that is specifically designed for panoramic
imaging of teeth, jaw, and oral structures.
The sensor consists of a CCD and other
components, and comprises a sensor drive
circuit and a signal processing circuit.
132 Panoramic/tomo An application or operating data program Class C
graphic dental x- designed for use in, or together with a
ray system panoramic/tomographic dental x-ray system
(orthopantomogr configuration.
aphy system)
application
softwareS. Device name Intended use Risk
No. Classification
133 Paranasal A reusable or single-use ultrasound Class B
ultrasound probe transducer assembly enclosed in a fluid-
resistant, acoustically and electrically
insulated housing that is intended to be
inserted into and positioned in the paranasal
sinuses by the operator. The device is also
called an endoscopic ultrasound probe or
ultrasound endoscopic transducer to be used
in the paranasal sinuses. the device is
typically incorporated in or used in
combination with a device that requires
ultrasonography guidance or ultrasonic wave
generation, such as an endoscopic device or
a needle biopsy device. The device is
composed of either a single transducer
element or an array of transducer elements
(also called piezoelectric elements, active
elements, or crystals), damping, backing, and
matching materials.
134 PET infusion An assembly of devices intended to deliver Class C
system accurate doses of 18F Fluorodeoxyglucose
(FDG) radiopharmaceuticals and commonly
used flushing solutions to patients during
molecular imaging (nuclear medicine)
diagnostic procedures. It may also be used to
provide effective radiation shielding to
medical personnel from Fluorine-18 (18F)
radiation exposure during nuclear medicine
diagnostic procedures. (Not meant for
pediatric populations).
135 PET system An assembly of devices comprising a Class C
diagnostic, positron emission tomography
(PET) imaging system used to detect, record,
quantify and analyse 511 kilo-electronvolt
(keV) photon emission patterns resulting from
annihilation reactions produced during the
decay of positron emitting
radiopharmaceuticals. It produces three-
dimensional (3-D) tomographic digital cross-
sectional physiological images representing
distribution patterns of positron emitting
radiopharmaceuticals ingested by, or injected
into the patient.
136 PET system An individual software program or group of Class B
application programs, routines or algorithms that add
software specific image processing and/or analysis
capabilities to a positron emission
tomography (PET) imaging system
configuration. A basic set of applications
programs and routines is included with such
computer-controlled imaging systems and
they can be upgraded to correctS. Device name Intended use Risk
No. Classification
programming errors or to add new system
capabilities.
137 PET/CT system A diagnostic radiological imaging system that Class C
is a combination of a positron emission
tomography (PET) camera system for nuclear
medicine (NM) images, and a computed
tomography (CT) camera system for x-ray
images. The nuclear medicine images and
the x-ray images may be registered and
displayed in a fused format (overlaid in the
same orientation) for the anatomical
localization of the nuclear medicine data (i.e.,
distribution of radiopharmaceuticals). The
PET and CT portions of the system may be
used independently or in combination.
138 PET/MRI system A diagnostic radiological imaging system that Class C
is a combination of a positron emission
tomography (PET) camera system for nuclear
medicine (NM) images, and a magnetic
resonance imaging (MRI) system for
magnetic resonance images. The nuclear
medicine images and the magnetic
resonance images may be registered and
displayed in a fused format (overlaid in the
same orientation) for the anatomical
localization of the nuclear medicine data (i.e.,
distribution of radiopharmaceuticals). The
PET and MRI portions of the system may be
used independently or in combination.
139 Photofluorograph A photofluorographic x-ray system is a device Class C
ic x-ray system that includes afluoroscopic x-ray unit and a
camera intended to be used to produce, then
photograph, a fluoroscopic image of the
body.
140 Pneumoencepha A pneumoencephalographic chair is a chair Class B
lographic chair, intended to support and position a patient
non powered during pneumoencephalography (x-ray
imaging of the brain).
141 Positron CT A system capable of performing both SPECT Class C
combined examination and positron CT (PET)
SPECT system examinationS. Device name Intended use Risk
No. Classification
142 Radiographic A radiographic film cassette is a device Class B
film cassette/X- intended for use during diagnostic x-ray
ray cassette procedures to hold a radiographic film in
close contact with an x-ray intensifying
screen and to provide a light-proof enclosure
for direct exposure of radiographic film
143 Radiographic A radiographic film/cassette changer is a Class B
film/cassette device intended to be used during a
changer radiologic procedure to move a radiographic
film or cassette between x-ray exposures and
to position it during the exposure.
144 Radiographic A radiographic film/cassette changer Class B
film/cassette programmer is a device intended to be used
changer to control the operations of a film or cassette
programmer changer during serial medical radiography.
145 Radiologic A radiologic quality assurance instrument is a Class A
quality device intended for medical purposes to
assurance measure a physical characteristic associated
instrument with another radiologic device.
146 Radiological Radiological computer aided triage and Class C
computer aided notification software is an image processing
triage and software intended to aid in prioritization and
notification triage of radiological medical images. The
software device notifies a designated list of clinicians
of the availability of time sensitive radiological
medical images for review based on
computer aided image analysis of those
images performed by the device.
147 Radiological A radiological computer-assisted diagnostic Class C
computer- software for lesions suspicious of cancer is
assisted an image processing prescription device
diagnostic intended to aid in the characterization of
software for lesions as suspicious for cancer identified on
lesions acquired medical images such as magnetic
suspicious of resonance, mammography, radiography, or
cancer computed tomography. The device
characterizes lesions based on features or
information extracted from the images and
provides information about the lesion(s) to
the user.
148 Radionuclide A radionuclide dose calibrator is a radiation Class B
dose calibrator detection device intended to assay
radionuclides before their administration to
patients.
149 Radionuclide A radionuclide rebreathing system is a device Class C
rebreathing intended to be used to contain a gaseous or
system volatile radionuclide or a radionuclide-labeled
aerosol and permit it to be respired by the
patient during nuclear medicine ventilatory
tests (testing process of exchange between
the lungs and the atmosphere).S. Device name Intended use Risk
No. Classification
150 Rectal/vaginal An invasive component of an ultrasound Class B
ultrasound imaging assembly designed to be positioned
imaging within the vagina and/or rectum, either
transducer manually or under endoscopic guidance, for
ultrasound imaging from within the
vagina/rectum. It may be intended for wired
or wireless data transfer and may be
intended for use with a dedicated ultrasound
system or with an off-the-shelf device (e.g.,
smartphone) with dedicated software
installed. This is a reusable device.
151 Software for A software, which is designed to process Class C
electrocardiogra data obtained from an electrocardiograph
ph with with ultrasound diagnostic system. The
ultrasonic resultant data are provided for diagnosis, etc.
diagnostic This term may involve the recording media
system where the software are stored.
152 SPECT system An individual software program or group of Class B
application programs, routines or algorithms that add
software specific image processing and/or analysis
capabilities to a positron emission
tomography (PET) imaging system
configuration. A basic set of applications
programs and routines is included with such
computer-controlled imaging systems and
they can be upgraded to correct
programming errors or to add new system
capabilities.
153 SPECT system, An assembly of devices comprising a Class C
annular detector diagnostic, stationary, single photon emission
array computed tomography (SPECT) system
designed exclusively for use in tomographic
imaging applications. It detects, records,
quantifies and analyses radionuclide
emissions produced during the decay of
radiopharmaceuticals or other radiation
emitting materials injected into, or ingested
by, a patient. Its imaging capabilities include
static and dynamic imaging applications and
three-dimensional (3-D) digital image
reconstruction/display at any angle including
axial, coronal and sagittal planes.
154 SPECT system, An assembly of devices comprising a Class C
rotating detector diagnostic single photon emission computed
head tomography (SPECT) system that is a three-
dimensional (3-D) tomographic imaging
gamma camera-based system used to
detect, record, quantify and analyse
radionuclide emissions (primarily gamma
rays) produced during the decay of
radiopharmaceuticals or other radiationS. Device name Intended use Risk
No. Classification
emitting materials injected into, or ingested
by, a patient.
155 SPECT/CT An assembly of diagnostic devices that Class C
system comprise a radiological imaging system that
is a combination of a single photon emission
computed tomography (SPECT) camera
system for nuclear medicine (NM) images,
and a computed tomography (CT) camera
system for x-ray images. The nuclear
medicine images and the x-ray images may
be registered and displayed in a fused format
(overlaid in the same orientation) for the
anatomical localization of the nuclear
medicine data (i.e., distribution of
radiopharmaceuticals). The SPECT and CT
portions of the system may be used
independently or in combination and the
images may be transferred to other systems
for radiation therapy planning or additional
processing.
156 Spot-film device A spot-film device is an electromechanical Class B
component of a fluoroscopic x-ray system
that is intended to be used for medical
purposes to position a radiographic film
cassette to obtain radiographs during
fluoroscopy.
157 Surgical A hand-held ultrasound imaging transducer Class C
ultrasound assembly designed to be positioned within a
imaging surgical site for localized intraoperative
transducer imaging applications. This group of devices
includes ultrasound imaging transducer
assemblies used with A-mode, B-mode, M-
mode, Doppler, colour Doppler (CD), and
duplex (combination imaging, Doppler and/or
colour flow) scanning capabilities. This is a
reusable device.
158 Thyroid-uptake An assembly of diagnostic devices that Class B
nuclear medicine comprise a non-imaging nuclear medicine
system system designed primarily for radioactive
iodine related thyroid uptake measurement
and analysis applications. It typically includes
a multichannel analyser, computer,
scintillation detector, detector support
equipment, an operator's console, videoS. Device name Intended use Risk
No. Classification
display, well counter detector, collimator,
shielding, and application software.
159 Tissue specimen An assembly of devices designed to produce Class A
x-ray an x-ray image of a tissue sample (e.g.,
tomography stereotactic biopsy cores taken during
system mammographic procedures) and/or an
amputated body part, by generating and
controlling x-ray beams and recording the
absorption patterns of the x-rays.
160 Transilluminator A transilluminator, also known as a Class C
for breast diaphanoscope or lightscanner, is an
evaluation/Breas electrically powered device that uses low
t transilluminator intensity emissions of visible light and near-
(Diaphanoscope) infrared radiation (approximately 700-1050
nanometers (nm)), transmitted through the
breast, to visualize translucent tissue for the
diagnosis of cancer, other conditions,
diseases, or abnormalities.
161 Transoesophage A mains electricity (AC-powered) device Class B
al vascular intended to be used for monitoring cardiac
ultrasound output and/or fluid status through connection
monitor to a dedicated probe, which is placed in the
oesophagus to measure blood flow in the
descending aorta. It is based on measuring
the ultrasonic frequency shift between
transmitted and reflected signals (Doppler
principle) and is displayed on the monitor as
a velocity/time waveform. It is typically used
during a surgical procedure or in intensive
care.
162 Transoesophage A device intended to be inserted into the Class B
al vascular oesophagus, orally or nasally, to continuously
ultrasound probe measure blood flow in the descending aorta
by ultrasonic Doppler technology for
assessment of cardiac output and/or fluid
status. It has multiple sensors at the distal
end and a connector at the proximal end. It is
typically used during general anaesthesia or
in intensive care. This is a single-use device.
163 Ultrasonic A unit used to amplify signals transmitted Class B
amplifier from the probe of an ultrasound imaging
system. This is used with an ultrasound
system in the event the quality of original
data transfer is lowered by the distanceS. Device name Intended use Risk
No. Classification
between the console and the imaging probe
in the ultrasound system.
164 Ultrasonic pulsed An ultrasonic pulsed doppler imaging system Class B
doppler imaging is a device that combines the features of
system continuous wave doppler-effect technology
with pulsed-echo effect technology and is
intended to determine stationary body tissue
characteristics, such as depth or location of
tissue interfaces or dynamic tissue
characteristics such as velocity of blood or
tissue motion.
165 Ultrasonic pulsed An ultrasonic pulsed echo imaging system is Class B
echo imaging a device intended to project a pulsed sound
system beam into body tissue to determine the depth
or location of the tissue interfaces and to
measure the duration of an acoustic pulse
from the transmitter to the tissue interface
and back to the receiver.
166 Ultrasound A collection of sterile devices that includes a Class B
aspiration biopsy biopsy needle and other supplies used to
procedure kit perform an ultrasound-guided aspiration
sampling of tissue. The needle tip must
provide a clearly visible image during
ultrasound imaging. This is a single-use
device.
167 Ultrasound A substance/formulation (e.g., solution, gel, Class A
contrast medium, foam) intended to be administered into the
transuterine female reproductive tract, via the
administration vagina/uterus, to enhance diagnostic
ultrasound images, typically for the evaluation
of the uterine cavity and/or fallopian tube
patency. (Invasive devices for application not
included)
168 Ultrasound A sterile balloon-like cap made of Hevea Class B
endoscope natural rubber latex (NRL) designed to be
balloon, Hevea- placed on the distal end of an ultrasound
latex endoscope and inflated to make contact with
the wall of the viscus to enable a higher-
quality ultrasound image during echo-
endoscopy, typically of the gastrointestinal or
respiratory tract. It is inflated with water
through the endoscope.S. Device name Intended use Risk
No. Classification
169 Ultrasound A sterile balloon-like cap made of a synthetic- Class B
endoscope polymer (e.g., silicone) designed to be placed
balloon, on the distal end of an ultrasound endoscope
synthetic and inflated to make contact with the wall of
polymer the viscus to enable a higher-quality
ultrasound image during echo-endoscopy,
typically of the gastrointestinal or respiratory
tract. It is inflated with water through the
endoscope.
170 Ultrasound An individual software program or group of Class B
imaging system programs, routines or algorithms that add
application specific image processing and/or analysis
software capabilities to a diagnostic ultrasound system
configuration. A basic set of applications
programs and routines are included with such
computer-controlled imaging systems and
they can be upgraded to correct
programming errors or to add new system
capabilities.
171 Ultrasound An electronic device intended to be used with Class B
imaging system an ultrasound (US) imaging system to enable
multi-transducer the simultaneous connection of multiple
connection unit hand-held US transducers so the user can
conveniently switch between transducers as
required. It is a unit with multiple transducer
ports and is typically attached to the US
imaging system stand.
172 Ultrasound Mainframe or personal computer (PC) based Class B
imaging system operating system software (or firmware)
operation specific to the central processing unit (CPU)
software incorporated into a diagnostic ultrasound
system configuration. This includes the
software or firmware based programs and
routines supplied by the computer
manufacturer that drive a specific computer in
the performance of its tasks and assists the
operators, applications programmers and
programs with various supporting functions.
173 Ultrasound A device that is a component of a diagnostic Class B
imaging system ultrasound imaging system that functions as
operator console the primary control panel. It includes
hardware and software that allows for image
display, processing, analysis, archiving and
retrieval. It typically includes the capabilities
to be interfaced into a picture archiving and
communication system (PACS), a local area
network (LAN), a radiology information
system (RIS) or a hospital information system
(HIS). It contains the primary controls for the
direct operation of the ultrasound system and
is typically incorporated in the system designS. Device name Intended use Risk
No. Classification
as is the case with mobile or portable
ultrasound systems.
174 Ultrasound A metal or plastic bracket intended to be Class B
imaging system applied to a hand-held ultrasound (US)
tracking transducer for the repeatable positioning
positioner, (detach from/reattach to same place) of an
reusable electromagnetic (EM) sensor and/or needle
(ultrasound guide on the transducer. It may be used in
transducer conjunction with an EM device tracking
bracket) system and is intended for applications
involving needle guidance and tracking such
as ablation, core tissue biopsy, fluid
aspiration, therapeutic delivery and vascular
access. (transducer and sensor are not
included)
175 Ultrasound A unit used to position an ultrasound system Class B
imaging imaging transducer that is inserted into the
transducer body through an endoscope. This device is
positioning unit an accessory to a diagnostic ultrasound
imaging system and it transmits electrical
signals that, after processing, will display the
position of a the transducer on a monitor.
This unit will assist the endoscopist in the
placement of the working transducer (the
probe) and to allow monitoring of the
movement after placement.
176 Ultrasound A dedicated electrically-powered unit Class B
imaging intended to be used to wash and disinfect
transducer ultrasound imaging transducers with the use
washer- of appropriate cleaning methods and
disinfector chemical disinfection. It is typically a stand-
(chemical) alone unit with a washing/disinfecting
chamber designed to accept an ultrasound
imaging transducer (probe). Not intended for
end disinfection.S. Device name Intended use Risk
No. Classification
177 Ultrasound A physiological monitoring device used as Class B
system one component in a diagnostic ultrasound
synchronizer system. This device produces signals which
can synchronize imaging acquisition and data
collection with specific measurable,
physiological parameters, such as the
starting point of a patient's respiratory or
cardiac cycle. It is used mainly to reduce
artifacts and to increase the signal-to-noise
ratio in real-time ultrasonic imaging and in
video imaging.
178 Ultrasound- An assembly of noninvasive devices intended Class C
guided laser for use during soft-tissue lesion treatment by
thermal therapy ultrasound-guided laser thermal therapy, to
needle guide provide software-based simulation of tissue
positioning thermal damage for assisting the manual
system positioning of percutaneous needles through
which laser applicators (not included) are
introduced. It consists of an electrically-
powered interface/display and needle guides
for attachment to a body-surface ultrasound
(US) imaging probe/transducer; the system
overlays real-time US images [from a
separate US system] with the predicted laser
thermal effect
179 Vascular A mains electricity (AC-powered) external Class B
ultrasound device, which may include internal
system control rechargeable batteries, intended to be used
unit to indicate (visually and/or sonically) blood
flow in a peripheral blood vessel, through
connection to a dedicated probe/catheter (not
included), using ultrasound/Doppler/transit
time technology. It may be intended to locate
and assess the extent of vascular flow
restriction (e.g., clots, stenosis, mechanical
damage) or to monitor blood flow in
association with microvascular surgery.
180 X-ray film A housing for x-ray film specifically designed Class B
cassette, to be used in, and work as part of, an
automatic film automated x-ray film changing system. The
changing housing is intended to be loaded with x-ray
film under appropriate darkroom conditions,
and is then inserted into the loading
magazine of the film changing system. After
exposure, it is held in a receiving magazine
until the operator removes it for final
processing.
181 X-ray film A device used in medical imaging Class B
cassette, manual applications to shield x-ray film from
exposure to room light during transport and
insertion into a diagnostic imaging system,
film formatter, or film processor.S. Device name Intended use Risk
No. Classification
182 X-ray film ruler A device used in radiology to superimpose Class A
accurate measurements of length (i.e., inches
or millimetres) onto an x-ray film so that these
measurements remain as a permanent
feature of that x-ray against the anatomical
structure that has been captured. It is made
of x-ray translucent material (e.g., plastic)
whilst the graduations are not translucent and
therefore show on the exposed x-ray film.
183 X-ray image A device that converts an x-ray image into a Class B
intensifier light image, then to an electronic image and
finally back to a light-based image of
diminished size and increased brightness. It
is primarily used in fluoroscopic,
angiographic, cine-fluorographic x-ray, and
digital x-ray applications as it outputs an
image small enough to be coupled to cine,
television or spot-film cameras.
184 X-ray system A dedicated mainframe computer, personal Class C
computer, computer (PC) or PC based platform and
diagnostic, associated hardware, firmware, and
general-purpose operating system software used specifically
to control and monitor the operation of a
general-purpose medical x-ray system and
associated image processing, display and
analysis functions.
185 X-ray system A physiological monitoring unit used as a Class C
synchronizer component of a diagnostic x-ray system, e.g.,
fluoroscopy, angiography or general-purpose,
that produces a signal which enables image
formation or data collection to be
synchronized with a specific measurable
physiological parameter, e.g., the beginning
of a patient's respiratory or cardiac cycle. It is
primarily used for the purpose of artifact
reduction or enhancement of signal-to-noise
ratios in various real-time or dynamic
diagnostic x-ray applications. It is sometimes
referred to as a gated imaging accessory or
trigger.
186 X-ray/CT A system combining a diagnostic X-ray Class C
combined computed tomography (CT) and a diagnostic
cardiovascular cardiovascular fluoroscopy system.
diagnostic X-ray
systemName of Category:
Radiotherapy
Total No. of Devices:
114Category: Radiotherapy
S.No. Device name Intended use Risk Class
1 Absorbable perirectal An absorbable perirectal spacer is Class C
spacer composed of biodegradable material
that temporarily positions the anterior
rectal wall away from the prostate
during radiotherapy for prostate cancer
with the intent to reduce the radiation
dose delivered to the anterior rectum.
2 Absorbable tissue spacer An absorbable material used to Class D
for radiotherapy reduce radiation exposure of normal
tissue during radiotherapy by
implanting surgically or percutaneously
between tissue, internal organs, etc.,
to make a space between the
malignant tumor and normal tissue.
3 Applicator for bile duct A manual brachytherapy applicator Class C
manual brachytherapy specifically designed for bile duct
radiation therapy. An applicator designed
to have a configuration that facilitates
manual placement (puncture or
placement and removal using an
endoscope or a diagnostic imaging
system) of single or multiple therapeutic
radiation sources in treatment sites in
the bile duct.
4 Applicator for bile duct A remote controlled brachytherapy Class C
remote after loading applicator specifically designed for bile
brachytherapy duct radiation therapy. It is designed to
be temporarily implanted in the bile duct.
It serves as a guide for computer-
controlled temporary placement and
removal of a single or multiple
therapeutic radiation sources at
treatment sites.
5 Applicator for bladder A manual brachytherapy applicator Class C
manual brachytherapy designed to facilitate manual placement
(puncture or placement and removal
using an endoscope or a diagnostic
imaging system) of single or multiple
therapeutic radiation sources in
treatment sites in the bladder.S.No. Device name Intended use Risk Class
6 Applicator for bladder A remote controlled Class C
remote after loading brachytherapy applicator specifically
brachytherapy designed for bladder radiation therapy. It
is designed to be temporarily implanted
in the bladder. It serves as a guide for
computer-controlled temporary
placement and removal of a single
or multiple therapeutic radiation
sources at treatment sites.
7 Applicator for A general-purpose brachytherapy Class C
brachytherapy non- applicator used to facilitate
central circulatory radiotherapy. A single or module
general-purpose manual applicator designed to facilitate manual
placement (puncture, local placement,
placement under endoscopy, and
placement and removal using an image
diagnostic system) of single or multiple
therapeutic radiation sources in
treatment sites in the non-central
circulatory system.
8 Applicator for A general-purpose remote controlled Class C
brachytherapy non- brachytherapy applicator used to
central circulatory facilitate radiotherapy. It is designed to
general-purpose remote be temporarily implanted in the body. It
after loading serves as a guide for computer-
controlled temporary placement and
removal of a single or multiple
therapeutic radiation sources at
treatment sites in the non-central
circulatory system.
9 Applicator for bronchial A manual brachytherapy applicator Class C
manual brachytherapy specifically designed for temporarily use
applicator in bronchial radiation therapy. A single
or module applicator designed to
facilitate manual placement (placement
using an endoscope or positioning,
placement and removal using a
diagnostic imaging system) of single
or multiple therapeutic radiation
sources in treatment sites. It may be
designed to be standard in
configuration or to handle specific
radiation sources.S.No. Device name Intended use Risk Class
10 Applicator for bronchial A remote controlled Class C
remote after loading brachytherapy applicator specifically
brachytherapy designed for bronchial radiation therapy.
It is designed to be temporarily
implanted in the body. It serves as a
guide for computer-controlled
temporary placement and removal of
a single or multiple therapeutic
radiation sources in the bronchus.
This device group includes various
applicators such as hollow needles,
tubes, and catheters, as well as
associated devices and connectors.
11 Applicator for A manual brachytherapy applicator Class C
cervical/endometrial specifically designed for uterine cervix
manual brachytherapy or intrauterine radiation therapy. A
single or module applicator designed to
facilitate manual placement (puncture,
placement with an endoscope or a
diagnostic imaging system) of
single or multiple
therapeutic radiation sources in
treatment sites.
12 Applicator for A remote-controlled brachytherapy Class C
Cervical/endometrial applicator specifically designed for
remote after loading uterine, cervical, or intrauterine radiation
brachytherapy therapy. It is designed to be temporarily
implanted in the body. It serves as a
guide for computer-controlled temporary
placement and removal of a single or
multiple therapeutic radiation sources in
the uterus, cervix and endometrium.
13 Applicator for esophagus A manual brachytherapy applicator Class C
manual brachytherapy specifically designed for esophagus
radiation therapy. A single or module
applicator designed to facilitate
manual placement (puncture or
placement and removal using an
endoscope or a diagnostic imaging
system) of single or multiple therapeutic
radiation sources in treatment sites in
the esophagus. It may be designed to be
standard in configuration or to handle
specific radiation sources.S.No. Device name Intended use Risk Class
14 Applicator for esophagus A remote controlled Class C
remote after loading brachytherapy applicator specifically
brachytherapy designed for esophagus radiation
therapy. It is designed to be
temporarily implanted in the
esophagus. It serves as a guide for
computer-controlled temporary
placement and removal of a single or
multiple therapeutic radiation sources.
This device group includes various
applicators such as hollow needles,
tubes, and catheters, as well as
associated devices and connectors.
15 Applicator for eye A template with a groove on the one Class C
manual brachytherapy side. The groove shows the position of
the brachytherapy source that is
manually, temporarily delivered to the
eye surface. The other side is shielded.
16 Applicator for eye remote A remote controlled Class C
after loading brachytherapy applicator specifically
brachytherapy designed for eye radiation therapy. It
serves as a guide for computer-
controlled temporary placement and
removal of a single or multiple
therapeutic radiation sources. This
device group includes various
applicators such as hollow needles,
tubes, and catheters, as well as
associated devices and connectors.
17 Applicator for A manual brachytherapy applicator Class C
nasopharynx manual specifically designed for
brachytherapy nasopharyngeal radiation therapy. A
single or module applicator
designed to facilitate manual
placement (puncture, endoscopic
placement or placement and removal
using a diagnostic imaging system) of
single or multiple therapeutic
radiation sources in treatment sites in
the nasopharynx.S.No. Device name Intended use Risk Class
18 Applicator for A remote controlled Class C
nasopharynx remote brachytherapy applicator specifically
after loading designed for nasopharyngeal
brachytherapy radiation therapy. It is designed to be
temporarily implanted in the body. It
serves as a guide for computer-
controlled temporary placement and
removal of a single or multiple
therapeutic radiation sources in the
nasopharynx.
19 Applicator for neck A manual brachytherapy applicator Class C
manual brachytherapy specifically designed for neck radiation
therapy. A single or module applicator
designed to facilitate manual placement
(puncture, local placement or placement
and removal using a diagnostic imaging
system) of single or multiple
therapeutic radiation sources in
treatment sites in the neck tissues.
20 Applicator for neck A remote controlled Class C
remote after loading brachytherapy applicator specifically
brachytherapy designed for neck radiation therapy. It
is designed to be temporarily implanted
in the neck tissues. It serves as a guide
for computer-controlled temporary
placement and removal of a single
or multiple therapeutic radiation
sources.
21 Applicator for pancreas A manual brachytherapy applicator Class C
manual brachytherapy specifically designed for pancreatic
radiation therapy. A single or module
applicator designed to facilitate
manual placement (puncture,
endoscopic placement, or placement
and removal using a diagnostic imaging
system) of single or multiple therapeutic
radiation sources in treatment sites in
the pancreas. It may be designed to be
standard in configuration or to handle
specific radiation sources.S.No. Device name Intended use Risk Class
22 Applicator for pancreas A remote controlled Class C
remote after loading brachytherapy applicator specifically
brachytherapy designed for pancreatic radiation
therapy. It is designed to be temporarily
implanted in the pancreas. It serves as a
guide for computer-controlled temporary
placement and removal of a single
or multiple
therapeutic radiation sources at
treatment sites.
23 Applicator for prostate A manual brachytherapy applicator Class C
manual brachytherapy specifically designed for prostate
radiation therapy. A single or
module applicator designed to
facilitate manual placement (puncture
or placement or removal with a trigger
loading device, an endoscope or a
diagnostic imaging system) of single or
multiple therapeutic radiation sources
in treatment sites in the prostate gland. It
may be designed to be standard in
configuration or to handle specific
radiation sources.
24 Applicator for prostate A remote controlled Class C
remote after loading brachytherapy applicator specifically
brachytherapy designed for prostate radiation therapy.
It is designed to be temporarily
implanted in the prostate gland. It
serves as a guide for computer-
controlled temporary placement and
removal of a single or multiple
therapeutic radiation sources.
25 Applicator for rectal/anal A manual brachytherapy applicator Class C
manual brachytherapy specifically designed for rectal and/or
anal radiation therapy. A single or
module applicator designed to
facilitate manual placement (puncture
or placement and removal using an
endoscope or a diagnostic imaging
system) of single or multiple therapeutic
radiation sources in treatment sites in
the rectum and/or anus.S.No. Device name Intended use Risk Class
26 Applicator for rectal/anal A remote controlled Class C
remote after loading brachytherapy applicator specifically
brachytherapy designed for rectal or anal radiation
therapy. It is designed to be temporarily
implanted in the rectum or anus. It
serves as a guide for computer-
controlled temporary placement and
removal of a single or multiple
therapeutic radiation sources.
27 Applicator for tongue A manual brachytherapy applicator Class C
manual brachytherapy specifically designed for lingual
radiation therapy. A single or
module applicator designed to
facilitate manual placement (puncture,
local placement or placement and
removal using a diagnostic imaging
system) of single or multiple therapeutic
radiation sources in treatment sites in
the tongue and the surrounding tissues.
It may be designed to be standard in
configuration or to handle specific
radiation sources.
28 Applicator for tongue A remote controlled Class C
remote after loading brachytherapy applicator specifically
brachytherapy designed for tongue or oral cavity
radiation therapy. It is designed to be
temporarily implanted in the tongue or
the surrounding tissues. It serves as a
guide for computer-controlled
temporary placement and removal of
a single or multiple therapeutic
radiation sources.
29 Applicator for vaginal A manual brachytherapy applicator Class C
manual brachytherapy specifically designed for vaginal or
transvaginal radiation therapy. A single
or module applicator designed to
facilitate manual placement
(puncture, local placement,
endoscopic placement or placement and
removal using a diagnostic
imaging system) of single or
multiple therapeutic radiation sources in
treatment sites.S.No. Device name Intended use Risk Class
30 Applicator for vaginal A remote controlled Class C
remote after loading brachytherapy applicator specifically
brachytherapy designed for vaginal or transvaginal
radiation therapy. It is designed to be
temporarily implanted in the body. It
serves as a guide for computer-
controlled temporary placement and
removal of a single or multiple
therapeutic radiation sources in the
vagina.
31 Blood vessel manual A manual brachytherapy applicator Class D
brachytherapy applicator designed exclusively for blood vessel
radiotherapy. Most commonly, it is used
to prevent formation of plaque, stenosis
and restenosis in blood vessels after
surgery. A single or module device
designed to facilitate manual placement
(placement and removal under
endoscopy or using an image diagnostic
system) of single or multiple
therapeutic radiation sources in the
treatment site.
32 Blood vessel remote A remote controlled brachytherapy Class D
after loading applicator designed exclusively for
brachytherapy applicator radiotherapy in blood vessels. This
treatment is used to prevent plaque
formation. and stenosis in blood vessels
after surgery. It is designed for
temporary implantation in a blood vessel,
and serves as a guide for computer-
controlled temporary placement and
removal of single or multiple therapeutic
radiation sources at treatment sites.
33 Brachytherapy needle A sterile, sharp bevel-edged, hollow Class B
tubular metal instrument that is used to
inject radionuclide into a body cavity or
tissue as a source of nuclear
radiation for cancer therapy
(brachytherapy).
34 Brachytherapy A device that consists of preserved Class B
radionuclide phantom, human or animal tissue, or a two or
anthropomorphic three-dimensional (3-D) tissue-
equivalent model designed to simulate
the functional, physical, or a
combination of these characteristics of
normal or diseased human organs.S.No. Device name Intended use Risk Class
35 Brachytherapy system A mains electricity (AC-powered) Class B
chair device (a chair or stool) that is a
component of a brachytherapy system
and which is specifically designed
to support and position a patient
during brachytherapy radiation
treatments given by either a manual
applicator or a
remote after loading brachytherapy
system applicator.
36 Brachytherapy system A component of a remote after Class C
remote after loading loading brachytherapy system
source safe consisting of a shielded vault, and
associated source retraction and
extrusion mechanisms, alarms, and
related mechanical, electronic and
software controls, used to shield the
brachytherapy sources in order to
protect system operators,
brachytherapy patients and others from
the continuous emissions of the
radioactive brachytherapy source(s)
when they are not in use.
37 Brachytherapy system The transfer tube, when attached to the Class C
remote after loading applicator and the after loading system,
source transfer tube provides a continuous closed passage
that allows for moving either a
radioactive source(s) and/or positioning
markers from the shielded source
storage compartment of the remote after
loading brachytherapy system into
appropriate positions within a
brachytherapy applicator that has been
positioned at a location either on the
surface of, or within, the patient.
38 Brain manual An applicator specifically Class D
brachytherapy applicator designed for brain radiotherapy. A
single or module applicator designed to
facilitate manual placement (puncture,
placement under endoscopy, or
placement and removal using an image
diagnostic system) of single or
multiple therapeutic radiation sources in
the brain.S.No. Device name Intended use Risk Class
39 Brain remote after A remote controlled brachytherapy Class D
loading brachytherapy applicator designed exclusively for
applicator brain radiotherapy for temporary
implantation in the body. It serves as
a computer- controlled guide for
temporary placement and removal
of a single or multiple therapeutic
radiation sources in the brain.
40 Breast brachytherapy A manual brachytherapy applicator Class C
system applicator, specifically designed for use in radiation
manual therapy treatments of the breast.
41 Breast brachytherapy A sterile, remote-afterloading Class C
system applicator, brachytherapy applicator specifically
remote-afterloading designed for use in radiation therapy
treatments of the breast. It is typically
designed for temporary implantation
within the breast and serves as a guide
for computer-controlled placement and
removal of single or multiple radioactive
sources.
42 Breast ductography A thin, sterile, semi-rigid or rigid Class C
cannula metal tube that is inserted into the
nipple of the female breast to inject a
contrast medium into the lactiferous
ducts to enhance their visualization
during a radiographic procedure.
43 Central circulatory A single or module applicator Class D
general-purpose manual designed to facilitate manual
brachytherapy applicator placement (puncture, local
placement, placement under endoscopy
or placement and removal using an
image diagnostic system) of single or
multiple therapeutic radiation sources
in treatment sites in the central
circulatory system.
44 Central circulatory Intended to be temporarily implanted Class D
general-purpose remote in the body. It serves as a guide for
after loading computer-controlled temporary
brachytherapy applicator placement and removal of a single
or multiple therapeutic radiation
sources at treatment sites in the
central circulatory system.S.No. Device name Intended use Risk Class
45 Central circulatory A device that places a radiation Class D
manual brachytherapy source manually or automatically at
therapeutic radionuclide the treatment site in the central
system circulatory system for providing a
required radiation dose during
radiotherapy. This device does not equip
a
remotely controlled radiation source
transporter.
46 Central circulatory A device for the central circulatory Class D
permanent implant system to be placed permanently in the
manual brachytherapy body for radiotherapy which is
therapeutic radionuclide necessary for treatment and
source symptomatic therapy, and uses natural
radioisotopes or radioisotopes produced
by an accelerator or a nuclear
reactor. The radiation source, which
is permanently placed manually, is
designed to achieve compatibility with
tissues. The radiation source can be
selected from the following forms –
e.g., microsphere, globe, stent, seed,
and wire- in order to generate low-
energy photons, beta particles, or alpha
particles.
47 Central circulatory A device for the central circulatory Class D
remote after loading system used as radiation source to
brachytherapy deliver a high or low dose rate with an
therapeutic radionuclide after-loading brachytherapy device
source designed for radiotherapy which is
necessary for treatment and
symptomatic therapy, and uses natural
radioisotopes or radioisotopes produced
by an accelerator or a nuclear reactor.
48 Central circulatory A device that places a radiation source Class D
remote after loading temporarily at the treatment site in the
brachytherapy central circulatory system for providing
therapeutic radionuclide a required radiation dose during
system radiotherapy. This device equips a
remotely controlled radiation source
transporter.S.No. Device name Intended use Risk Class
49 Central circulatory A device for the central circulatory Class D
temporary placement system that uses natural radioisotopes
manual brachytherapy or radioisotopes produced by an
therapeutic radionuclide accelerator or a nuclear reactor, and
source is placed in the body temporarily, and
removed after the pre-determined
treatment period. The radiation
source, which is temporarily inserted
manually, is supplied in various forms
– e.g., encapsulated, sealed, plated,
foiled, or embedded.
50 Compact Thermoluminescence dosimeter (TLD) Class A
thermoluminescent is used to measure the radiation
dosimetry electrometer dose emitted to the phantom, eyes
and other organs with high radio
sensitivity.
51 Conformal The intended use of the device is for the Class C
Brachytherapy Source treatment of cancer by temporary
intraoperative or surface irradiation.
The device contains radioactive material
with activity up to 200 mci and is
indicated for treatment of temporary
intraoperative, interstitial, intracavitary
or surface application to treat selected
localized tumors.
52 Coronary artery A sterile flexible tube intended to Class D
brachytherapy system deliver/remove radiation therapy sources
applicator, manual into a coronary artery, typically into the
lumen of an implanted stent, as part of a
manual afterloading brachytherapy
system
53 Coronary artery A sterile flexible tube intended to Class D
brachytherapy system deliver/remove radiation therapy sources
applicator, remote into a coronary artery, typically into the
afterloading lumen of an implanted stent, as part of a
remote-controlled afterloading
brachytherapy systemS.No. Device name Intended use Risk Class
54 Fluoroscopy/angiography A powered table designed to support Class B
table, powered and position a patient during
fluoroscopy/angiography typically in
conjunction with a cardiovascular
intervention or other minimally-invasive
surgical intervention (e.g., biopsy). It has
a flat table top with electronic controls for
table top positioning and/or motion
relative to the x-ray beam. It is not
dedicated to breast biopsy, and is not
intended for other specialized surgeries
(i.e., it is not a specialized operating
table with x-ray transparent features).
55 Gamma knife for A set of devices that are designed to Class D
radiotherapy/surgery uses very precise beams of gamma rays
to treat an area of disease (lesion) or
growth (tumor), especially in the brain,
upper spine and in certain cases,
vascular abnormalities.
56 General-purpose A general-purpose brachytherapy Class C
brachytherapy system applicator designed to facilitate delivery
applicator, manual of radiation therapy treatments that are
not specific to a particular anatomical
region. It is an individual or modular
device designed to facilitate manual
placement, e.g., puncture, topical
placement, endoscopically guided
placement or diagnostic imaging system
guided placement, and removal of single
or multiple radioactive sources at a
treatment site.
57 General-purpose A general-purpose remote-afterloading Class C
brachytherapy system brachytherapy applicator intended to be
applicator, remote- used to facilitate the delivery of radiation
afterloading therapy treatments in a range of
anatomical regions (e.g., liver, kidneys,
lungs, gastrointestinal tract). It is
designed for temporary introduction into
the body and functions as a guide for
computer-controlled placement and
removal of single or multiple radioactive
sources in a treatment area.S.No. Device name Intended use Risk Class
58 High-frequency A system used to generate high- Class C
hyperthermia system temperatures and to control the
provision of heat to the body in the
treatment of malignant and benign
tumors, or other diseases.
59 Interventional radiology A collection of various Class C
percutaneous-access kit instruments/devices (e.g., introducer
sheath, dilator, guides, cannula, needle,
angiographic catheter) intended to be
used for percutaneous body-access to
facilitate a radiological image-guided
interventional radiology or surgical
procedure [e.g., bile duct biopsy,
percutaneous transhepatic
cholangiogram, non-vascular drainage
procedures, ultrasound-guided spinal
surgery]. Some types are designed to
function as a channel to facilitate the
introduction of radiological image
guidance devices (e.g., ultrasound
probe/transducer) [not included]. It does
not contain pharmaceuticals.
60 Intra-vaginal organ A device that is specifically designed to Class B
positioning device for be inserted in the vagina to properly
diagnostic imaging and position and fix the surrounding organs
radiotherapy such as uterine cervix, rectum, and
urinary bladder for image diagnosis or
radiotherapy. This device is used to
facilitate reproducible positioning for
continuous image examination or
continuous radiotherapy.
61 Laser irradiation therapy A kit includes a puncture needle, a Class B
kit guide wire, and a guiding sheath for
guiding probes (used for laser
irradiation therapy, for example).
Not all of the components are
included; in some products, two or more
of components are integrated into one.
62 Living tissue A low energy X-ray therapy system Class C
radiotherapy system designed to treat adjacent tumor
lesions with high dose X-rays by placing
soft X-ray beams from 5 to 50 kV inside
the tumor tissue. It is used in both
intraoperative radiation and stereotactic
localized radiation therapy.S.No. Device name Intended use Risk Class
63 Manual brachytherapy A device that is a naturally-occurring, Class D
source, permanent accelerator- or reactor-produced
implant radioactive isotope and intended to be
permanently implanted into the body in
order to deliver curative or palliative
radiotherapy treatments. Manually
implanted sources intended for
permanent implantation are designed to
be histocompatible. It may take the form
of, e.g., microspheres, spheres, stents,
seeds or wires selected for producing
low energy photons, beta or alpha
particles.
64 Manual brachytherapy A device that is a naturally-occurring, Class C
source, temporary accelerator- or reactor-produced
placement radioactive isotope in a form that is
intended for temporary placement in the
body and removal after a specified
treatment time. It is used in
brachytherapy applications that require
direct manual or endoscopically-guided
placement and removal. Manually
inserted sources intended for temporary
placement come in a variety of forms,
e.g., encapsulated, sealed, plated, foil or
embedded sources.
65 Manual brachytherapy An assembly of therapeutic, independent Class C
system devices, manually brought together and
intended to deliver a palliative or
therapeutic radiation dose to an
anatomical region from radionuclide
sources. Medical personnel manually
place multiple radioactive sources in
appliances and applicators for either
permanent or temporary delivery at the
topical, interstitial, intraluminal, or
intracavitary brachytherapy treatment
site.
66 Manual-afterloading A collection of sterile devices intended to Class B
brachytherapy system dispense/collect hydraulic fluid used to
source delivery deliver the radiation source train of a
procedure kit manual-afterloading brachytherapy
system source transfer device to/from
the delivery catheter/applicator. It
consists of disposable devices such as
syringes, fluid collection bags,
adaptors/connectors.S.No. Device name Intended use Risk Class
67 Manual-afterloading A non-sterile radiation-shielding plastic Class C
brachytherapy system box intended to store a manual-
storage container afterloading brachytherapy system. It is
typically temporarily used as a safety
container to prevent radiation leakage in
the event of procedural difficulties.
68 Medical charged- particle A medical charged-particle radiation Class C
radiation therapy system therapy system is a device that
produces by acceleration high
energy charged particles (e.g., electrons
and protons) intended for use in
radiation therapy.
69 Medical neutron radiation A medical neutron radiation therapy Class C
therapy system system is a device intended to generate
high-energy neutrons for radiation
therapy
70 MOSFET radiation An assembly of devices using Class B
therapy dosimetry metal oxide semiconductor field-
system effect transistor (MOSFET)
technology intended to be used for on-
the-spot patient or anthropomorphic
radiation dose verification and
monitoring during radiation therapy
and radiology procedures.
Applications typically include radiation
oncology therapy and dosimetry,
treatment plan verification for in
vivo dosimetry, brachytherapy,
intraoperative radiation therapy, image-
guided radiation therapy, and research.
71 Non-central circulatory A device that places a radiation Class C
manual brachytherapy source manually or automatically at
therapeutic radionuclide the treatment site in the non-central
system circulatory system for providing a
required radiation dose during
radiotherapy.
72 Non-central circulatory A non-central cardiovascular Class C
permanent implant device which is histocompactible
manual brachytherapy and containing an isotope naturally
therapeutic radionuclide occurring or produced by an
source accelerator or a nuclear reactor,
intended to be permanently implanted
in the body for radiation therapy
requiring treatment or symptomatic
treatment.S.No. Device name Intended use Risk Class
73 Non-central circulatory A device for the non-central circulatory Class C
remote after loading system used as radiation source to
brachytherapy deliver a high or low dose rate with an
therapeutic radionuclide after-loading brachytherapy device
source designed for radiotherapy which is
necessary for treatment and
symptomatic therapy, and uses natural
radioisotopes or radioisotopes produced
by an accelerator or a nuclear
reactor.
74 Non-central circulatory A device that places a radiation source Class C
remote after loading temporarily at the treatment site in the
brachytherapy non-central circulatory system for
therapeutic radionuclide providing a required radiation dose
system during radiotherapy. This device
equips a remotely controlled
radiation
source transporter.
75 Non-central circulatory A non-central cardiovascular device Class C
temporary placement containing an isotope naturally
manual brachytherapy occurring or produced by an
therapeutic radionuclide accelerator or a nuclear reactor,
source intended to be temporarily implanted
in the body and to be removed after
a prescribed duration of treatment.
Used in brachytherapy, the device
is placed and removed
manually or under endoscopic
observation.
76 Patient positioning A device that is specifically designed to Class B
device for breast properly position and fix a female
diagnostic imaging and patient's breasts and chest for image
radiotherapy diagnosis, image-guided surgery,
interventional therapy, or radiotherapy.
77 Patient positioning A device that is specifically designed to Class B
device for extremity properly position and fix a patient's arms
diagnostic imaging and and legs for image diagnosis, image-
radiotherapy guided surgery, interventional therapy, or
radiotherapy.
78 Patient positioning The device that consists of frames, Class B
device for pelvis plates, or other parts, and is specifically
diagnostic imaging and designed to properly position and fix the
radiotherapy patient's abdomen and pelvic region
for image diagnosis, image-guided
surgery, interventional therapy,
or radiotherapy.S.No. Device name Intended use Risk Class
79 Patient positioning A device that consists of fixed or Class B
device for whole body adjustable parts (e.g., frames and
diagnostic imaging and plates), and is specifically designed to
radiotherapy properly position and fix the patient's
whole body for image diagnosis,
image-guided surgery, interventional
therapy, or radiotherapy.
80 Patient Positioning An assembly of devices used to locate, Class C
System, Ultrasound with ultrasound, internal soft-tissue
anatomy that moves relative to
external or bony landmarks, to enable
subsequent adjustment of the patient
for precise external beam radiation
treatment of the target tissue. It
typically includes an ultrasound
imaging system, computerized
workstation(s), optical tracking devices,
and dedicated software.
81 Post Breast Biopsy Intended to achieve and maintain Class C
Hemostatic Breast hemostasis of a breast biopsy wound
Compression Device site.
82 Powered neutron therapy A programmable bed for radiotherapy Class B
table designed to adjust the patient's posture
and immobilize the patient for
treatment that uses neutron rays that are
generated from the nuclear reactor, etc.
83 Powered patient table for A bed operates by programmable Class B
accelerator for electric radiotherapy designed to
adjust the patient's posture and
immobilize the patient for radiotherapy
that uses medical linear accelerator or
non-linear accelerator.
84 Powered radiation A powered radiation therapy patient Class C
therapy patient support support assembly is an electrically
assembly powered adjustable couch intended to
support a patient during radiation
therapyS.No. Device name Intended use Risk Class
85 Powered radionuclide A programmable bed for radiotherapy Class B
brachytherapy table designed to adjust the patient's posture
and immobilize the patient for
treatment that uses an after loading
short-distance irradiation treatment
apparatus that is operated
manually or electrically.
86 Powered remote A programmable electrically Class B
irradiation therapy table operated bed for radiotherapy
designed to adjust the patient's
posture and immobilize the patient for
treatment that uses a remote cobalt
60 radiotherapy apparatus and other
remote radionuclide radiotherapy
apparatuses.
87 Powered X-rays radiation A programmable electrically Class B
therapy table operated bed for radiotherapy
designed to adjust the patient's
posture and immobilize the patient for
treatment that uses an X-ray therapy
apparatus.
88 Radiation therapy beam- A radiation therapy beam-shaping Class C
shaping block block is a device made of a highly
attenuating material (such as lead)
intended for medical purposes to modify
the shape of a beam from a radiation
therapy source
89 Radiation therapy digital An automated device that is typically Class C
imager mounted on the gantry of a linear
accelerator and intended to produce
digital images of x-rayed anatomical
landmarks to guide radiation treatment
(e.g., tracking/targeting tumours). The
device may be a digital imaging panel
(e.g., of silicon) on robotic arms; it may
also have an x-ray source to generate
higher quality images.
90 Radiation therapy A radiation therapy simulation system is Class C
simulation system a fluoroscopic or radiographic x-ray
system intended for use in
localizing the volume to be exposed
during radiation therapy and confirming
the position and size of the
therapeutic irradiation field produced.S.No. Device name Intended use Risk Class
91 Radiological image A device intended to be implanted within Class C
marker, implantable the body, either temporarily or
permanently, to create identifying marks
that can be seen on radiographic film or
digital images. It is typically in the form of
a wire, needle, bead, clip, stent-like tube,
washer or fluid, and used to locate and
delineate a tumour, lesion, or other site
of interest. It is made from materials
compatible with the imaging system with
which it is intended to be used [e.g.,
magnetic resonance imaging (MRI), x-
ray, or nuclear medicine]; it may be
intended for use during radiotherapy
procedures.
92 Radionuclide A radionuclide brachytherapy source Class C
brachytherapy source is a device that consists of a
radionuclide which may be enclosed in a
sealed container made of gold, titanium,
stainless steel, or platinum and
intended for medical purposes to be
placed onto a body surface or into a
body cavity or tissue as a source of
nuclear radiation for therapy
93 Radionuclide dynamic A device used to measure and Class B
function testing record temporal variations of
equipment radioisotope concentrations in the
body. Specialized devices, such as
devices for thyroid uptake measurement,
renograms, and radioisotope blood
volume measurement, are included.
94 Radionuclide radiation A radionuclide radiation therapy Class C
therapy system system is a device intended to permit
an operator to administer gamma
radiation therapy, with the radiation
source located at a distance from the
patient's body.
95 Radionuclide source for Radiation sources generated in a reactor Class C
remote irradiation and used as in a remote after loading
therapy system designed to deliver a
therapeutic radiation beam to a target
anatomical area. The radiation sources
incorporated as a component of the
remote after loading system are
generally sealed.S.No. Device name Intended use Risk Class
96 Radionuclide system Intended to precisely determine the Class C
contour detector for outline of the area of the body to be
remote irradiation irradiated. Usually, the information
therapy obtained from this device is entered into
a radiotherapy planning system and
utilized for the radiotherapy plan.
97 Real-time position An assembly of electronic devices Class C
management respiratory designed to track the respiratory pattern
gating system, optical of a patient by means of optical
technology to correlate tumour
position with the respiratory cycle
during radiation treatment planning,
radiotherapy, computed tomography
(CT) imaging, or other radiation
procedures.
98 Rectal balloon for A rectal balloon for prostate Class C
prostate immobilization immobilization is a single use, inflatable,
non-powered positioning device placed
in the rectum to immobilize the
prostate in patients undergoing
radiation therapy.
99 Remote controlled A remote controlled radionuclide Class C
radionuclide applicator applicator system is an
system electromechanical or pneumatic
device intended to enable an operator
to apply, by remote control, a
radionuclide source into the body or to
the surface of the body for radiation
therapy.
100 Remote-afterloading A device that is a naturally-occurring, Class C
brachytherapy source accelerator or reactor produced-
radioactive isotope used as a source of
radiation in high or low dose rate remote
afterloading brachytherapy systems
designed to deliver curative or palliative
radiotherapy treatments. Sources used
in remote afterloading radiotherapy
systems may come in a variety of
strengths and physical forms, e.g., single
encapsulated source (sealed source),
ribbons, plated, foil or embedded
sources or contained radioactive liquids
or gels.S.No. Device name Intended use Risk Class
101 Remote-afterloading An assembly of devices using a Class C
brachytherapy system remotely-controlled radioactive source
transport system designed to deliver a
therapeutic or palliative radiation dose
from a single source or source train to an
anatomical region by placing the
radioactive source(s) temporarily on or in
the treatment site.
102 Stereotactic radiosurgical An assembly of devices designed to Class C
system deliver a therapeutic radiation dose to an
anatomical region from external beams
produced from multiple radionuclide
sources arranged in a fixed focal point
collimated array; typically used to treat
brain, neck, breast and spinal tumours. It
typically consists of: 1) a stereotactic
positioning device attached to the patient
to define the three-dimensional (3-D) co-
ordinates of the treatment site; 2) fixed
diameter collimators; 3) high-density
beam blockers; 4) a shielded housing to
hold the sources, reducing room
radiation; 5) a precision aligned array to
cause the source beams to intersect at a
single point; and 6) a moveable patient
table.
103 Stereotactic radiotherapy A stereotactic radiation therapy Class C
accelerator system system for treatment based on a linear
accelerator (or microtron). The device
may be used to inactivate lymphocytes.S.No. Device name Intended use Risk Class
104 Teletherapy radionuclide A device that is a component of a Class B
system table, powered teletherapy radionuclide system
(commonly known as a cobalt therapy
machine) and that is a
powered/programmable table specifically
designed to position and support a
patient during treatments administered
using a therapeutic radionuclide
teletherapy system (e.g., a Cobalt-60
teletherapy system). It has electronic
and/or software controls for table top
height and positioning. It can be a
stationary or mobile unit, or incorporated
as an integral component of a
radionuclide teletherapy system or
gantry configuration.
105 Teletherapy radionuclide A stationary assembly of computer- Class C
system, based devices designed to deliver a
conventional/Cobalt therapeutic radiation dose to an
therapy machine anatomical region from a single external
radiation beam produced by a
radionuclide source, typically to treat
malignant tumours; it does not provide
image-guided radiation therapy (IGRT)
functionality during treatment delivery.
106 Therapeutic x-ray high It is a device that is intended to supply Class B
voltage generator and control the voltage and electrical
energy to provide a therapeutic x-ray
system (e.g., brachytherapy) with the
power needed to produce an x-ray beam
of the desired voltage (kV) and current
(mA).
107 Ultraviolet Extracorporeal An assembly of devices used for Class C
Photopheresis system extracorporeal photoimmunetherapy to
treat immune disorders, especially
cutaneous T-cell lymphoma (CTCL). It
irradiates the leukocyte-rich fraction of
peripheral blood by UVA radiation
extracorporeally and returns back the
treated and untreated blood to the
patient. This system may or may not use
a UV-active drug (either ingested by
patient or injected into the leukocyte-rich
fraction of the extracted peripheral
blood).S.No. Device name Intended use Risk Class
108 Ultraviolet Photopheresis A collection of devices used as part of a Class C
system blood set photopheresis system for extracorporeal
photoimmunetherapy to treat immune
disorders, especially cutaneous T-cell
lymphoma (CTCL). It typically consists of
tubing (patient and fluid lines), fluid/blood
component bags, a dedicated centrifuge
bowl, a photoactivation chamber,
connectors, and clamps. It conducts
blood from the patient to the system's
main unit, aids in blood processing, and
returns leukocyte-enriched and
untreated components of the blood after
irradiation. This is a sterile, single-use
device.
109 Ultraviolet Photopheresis An assembly of ultraviolet A (UVA)- Class C
system lamp assembly emitting tubular strip lights that is an
exchangeable component of a
photopheresis system, and used to
irradiate blood components during
extracorporeal photoimmunetherapy to
treat immune disorders, especially
cutaneous T-cell lymphoma (CTCL).
110 X-ray CT system for A X-ray CT system that has a Class C
radiotherapy planning special configuration, containing
hardware, software, etc. used in
radiotherapy planning. It is used to
determine the size and positioning of
the therapeutic radiation field based
on a series of treatment parameters to
be generated.
111 X-ray radiation therapy An x-ray radiation therapy system is a Class C
system device intended to produce and control
x-rays used for radiation therapy.
112 X-ray/CT combined A combined system of a linear Class C
linear accelerator system accelerator system and an X-ray CT
system for radiotherapy planning.
113 X-ray/CT combined A combined system of particle Class C
particle radiotherapy radiotherapy equipment and an X-ray CT
equipment system for radiotherapy planning.S.No. Device name Intended use Risk Class
114 X-ray/MR combined A system intended to provide treatment Class C
linear accelerator system planning, image- guided stereotactic
radiosurgery and precision radiotherapy
for lesions, tumors and conditions
anywhere in the body where radiation
treatment in indicated. The system
operates on the principle of linear
acceleration of electrons, providing a
predictable radiation field in a beam of
well-defined dimensions.Name of Category:
Oncology
Total No. of Devices:
75Category: Oncology
S. No. Device name Intended use Risk
Class
1 Accelerator system A seat, typically with legs, that is a component of a Class C
chair therapeutic accelerator system, and used to support
and position a seated patient during radiation
therapy treatments involving the use of either a
medical linear accelerator or non-linear accelerator.
2 Accelerator system An instrument specifically designed to be used to Class C
quality assurance check the calibration and performance of linear and
device non-linear medical accelerator systems used for
radiation therapy applications, for
quality assurance (QA) purposes.
3 Alternating electric An assembly of portable devices designed to apply Class D
field antimitotic low-intensity, intermediate-frequency (100-300 kHz)
cancer treatment alternating electric fields to treat certain forms of
system recurrent or newly-diagnosed cancer; typically
glioblastoma multiforme (GBM) [malignant brain
tumour].
4 Alternating electric Alternating electric fields therapy is a novel Class C
field antimitotic anticancer treatment that disrupts tumor cell mitosis.
cancer treatment
system transducer
array
5 Alternating electric Alternating electric fields therapy is a novel Class C
field anticancer treatment that disrupts tumor cell mitosis.
antimitotic cancer
treatment system
generator
6 Anorectal A remote afterloading brachytherapy applicator Class C
brachytherapy specifically designed for use in radiation therapy
system applicator, treatments of the rectum and/or anus.
remote-afterloading
7 Anorectal A manual brachytherapy applicator specifically Class C
brachytherapy designed to be used in radiation therapy treatments
system applicator, of the rectum and/or anus.
manual
8 Balloon A collection of sterile surgical instruments and Class C
kyphoplasty kit devices used for the reduction of a vertebral
compression fractures (VCFs) caused by trauma,
cancer, or osteoporosis during a minimally invasive
procedure commonly known as balloon kyphoplasty.
9 Bladder instillation A sterile buffer solution intended to be used Class B
buffer solution exclusively for bladder instillation to help create an
optimal environment necessary for the effective
treatment of superficial bladder cancer with a
chemotherapy agent.S. No. Device name Intended use Risk
Class
10 Brachytherapy A sterile, bioabsorbable device designed to separate Class C
source spacer radioactive sources of the seed type that are
permanently implanted in close proximity to a
selected localized tumour, to increase the
distribution of radioactivity to the tumour.
11 Brachytherapy A mains electricity (AC-powered) component of a Class C
system remote- remote- afterloading brachytherapy system intended
afterloading to function as the primary control panel for the
operator console remote afterloader. It typically includes hardware
and software that allows for information display
and/or transfer, data processing, analysis, and
information archiving functions; it may also be
intended to interface with other devices (e.g.,
radiation therapy treatment planning computer) as
part of a picture archiving and communication
system (PACS).
12 Breast 3-D infrared An assembly of mains electricity (AC-powered) Class C
imaging/vascular devices intended for three-dimensional (3-D) breast
analysis system imaging and breast vascular analysis, typically used
with mammography screening to perform a breast
cancer risk examination.
13 Breast A sterile, remote-afterloading brachytherapy Class C
brachytherapy applicator specifically designed for use in radiation
system applicator, therapy treatments of the breast. It is typically
remote-afterloading designed for temporary implantation within the
breast and serves as a guide for computer-controlled
placement and removal of single or multiple
radioactive sources. Included are various types of
applicators such as hollow needles, tubes, or
catheters, and their associated components. This is
a
single-use device.
14 Breast A mains electricity (AC-powered) transilluminating Class C
transilluminator device with a built-in light source using low intensity
emissions of visible light and near-infrared radiation
(700 to 1050 nm) that is transmitted through the
female breast to visualize translucent tissue for the
diagnosis of cancer, or other conditions, diseases or
abnormalities. This device may also be known as a
diaphanoscope.
15 Breast ultrasound An assembly of mains electricity (AC-powered) Class C
imaging system devices designed for intracorporeal
(endosonography or endoscopic) ultrasound imaging
procedures involving the breast. It typically includes
special imaging tables used to optimize the ability to
give reproducible images of the breast.
16 Breast ultrasound An assembly of mains electricity (AC-powered) Class B
imaging system devices designed for extracorporeal ultrasound
imaging procedures involving the breast. It typically
includes special imaging tables used to optimize the
ability to give reproducible images of the breastS. No. Device name Intended use Risk
Class
17 Cancer diagnostic A device intended for detection of breast cance Class C
probe lesions of various subtypes intraoperatively by
checking for tumour side margins.
18 Capsular tension A circular band intended to be used to enhance the Class C
ring mechanical
stability of a subluxated crystalline lens capsule in
the presence of weak or absent supporting zonules.
19 Cervical cone knife A surgical, manually-operated, instrument that is Class C
inserted into the vagina and designed for excising a
sample of abnormal tissue, e.g., indicated by the
presence of precancerous changes, from the cervix.
20 Cervical cytology A hand-held, manual, blunt surgical instrument Class B
scraper, single-use designed to scrape and retrieve cytological material
from the surface of the cervix (neck of the uterus) or
vaginal area for pathological examination and
diagnosis, often for the detection of cervical cancer.
This is a single-use device.
21 Colonic cytology A collection of non-sterile devices intended to collect Class B
sampling set exfoliated colonic cells (colonocytes) from the
surface of human rectal mucosa for colorectal
cancer investigation and/or patient screening.
22 Computer A standalone software application intended to be Class C
vision/Machine used to scan radiological images (X-ray, CT scan,
learning-aided etc.) in order to screen/diagnose for cancerous
software tissues using machine learning-based training
application for models and computer vision.
cancer detection
23 Coronary artery A sterile flexible tube intended to deliver/remove Class D
brachytherapy radiation therapy sources into a coronary artery,
system applicator, typically into the lumen of an implanted stent, as part
manual- of a manual-afterloading brachytherapy system. It is
afterloading introduced into the patient and subsequently
connected to the brachytherapy system source
transfer device; it includes radiopaque markers to
monitor the position of the radiation source.
Disposable devices associated with the procedure
may be included (e.g., syringe, connectors). This is a
single-use device.
24 Cryosurgical set A sterile collection of disposable devices used in Class C
conjunction with a cryosurgical unit as well as
monitoring and other devices to perform a surgical
technique that involves freezing a targeted area of
tissue to damage and destroy cancer cells in the
unwanted portions.
25 Electro cancer An assembly of devices designed for the treatment Class C
therapy system of tumours and the destruction of their cancerous
cells using low-voltage direct current of small
intensity delivered via electrodes placed across the
affected
body area.S. No. Device name Intended use Risk
Class
26 Electronic clinical A portable assembly of devices designed to Class B
breast examination electronically measure, map, document and store
system information about breast lesions/masses with regard
to shape, size, location, consistency/relative
hardness during a clinical breast examination (CBE).
27 Electroporation A mobile assembly of devices designed to apply Class C
therapy system electrical impulses to the tissue to enable
electroporation, a phenomenon that induces
alteration in the structure of cell membranes to
increase their permeability and allow molecules that
usually cannot enter the cell membrane, such as
drugs [electrochemotherapy (ECT)] and genetic
materials [electrogenetherapy (EGT)], to reach the
cytoplasm.
28 Electroporation A sterile, patient-contact component of an Class C
therapy system electroporation therapy system intended to fit onto
endoscopic the distal tip of an endoscope and connect to an
applicator electroporation therapy system generator to deliver
electrical impulses to tissues during endoscopy as
part of electroporation, a phenomenon that induces
alteration in the structure of cell membranes to
increase their permeability and allow molecules that
usually cannot enter the cell membrane, such as
drugs [electrochemotherapy (ECT)], to reach the
cytoplasm.
29 Embolization A bioabsorbable, implantable bead/microsphere Class D
particle, intended to be used to temporarily occlude an artery
bioabsorbable supplying hyperplastic/neoplastic tissue in a variety
of anatomies (e.g., liver, lung, breast, bladder,
uterus, head or neck); it does not include a
pharmaceutical agent. It may be used independently
to create ischemia in the tissue, or as an adjuvant in
combination with cytostatic agents and other
antitumour drugs to help optimize intra-tumour drug
accumulation for interventional radiology and
visceral surgery procedures. It is typically available
as an injectable solution containing numerous
microspheres [e.g., degradable starch microspheres
(DSM)].
30 Embolization A non-bioabsorbable, implantable bead/microsphere Class D
particle, non- intended to be introduced into the peripheral
bioabsorbable vasculature during an interventional radiology
procedure to treat hypervascularized tumours and
arteriovenous malformation in a variety of anatomies
(e.g., head, neck, spine, liver, genitourinary tract,
uterus, gastrointestinal, limbs and lungs). It is
typically available as injectable solution containing
numerous microspheres [e.g., compressible
polyvinyl alcohol (PVA) microspheres] intended to
permanently obstruct blood flow to the
tumour/malformation.S. No. Device name Intended use Risk
Class
31 Endocervical A collection of devices designed to remove Class C
aspirator superficial tissue from the mucous membrane lining
the cervical canal (endometrium) through manually-
powered suction.
32 Externally- A non-sterile endoscope with a highly flexible sleeve Class B
propelled flexible and distal tip intended for the visual examination of
video colonoscope the entire adult colon [lower gastrointestinal (GI)
tract].It is used for the screening of colorectal cancer
and the detection of other diseases of the lower GI
tract. This is a single-use device.
33 Extravascular- An assembly of devices designed to produce and Class B
circulation control heated fluids circulated within a vessel
hyperthermia applied to the body (e.g., vest, mattress, jacket,
system band, pad, body wrap, catheter, probe) for systemic
or localized heating to treat malignant tumours,
benign growths, or other disease-related conditions.
34 Extravascular- A vessel applied to the outside of the body (e.g., in Class A
circulation the form of a jacket, vest, body wrap, cushion,
hyperthermia blanket, or mattress) that incorporates tubing
system applicator, through which heated fluids are circulated for
extracorporeal systemic or localized heating to treat malignant
tumours, benign growths, or other disease-related
conditions. The applicator typically includes a
thermometry component that monitors the
temperature of the applicator during operation. The
applicator includes tubing, cables, and connectors
that interface with the hyperthermia system's control
unit during treatments. It is typically used in an
oncology department. This is a reusable device.
35 Extravascular- A component of a hyperthermia system that typically Class C
circulation consists of catheter-enclosed tubing which is
hyperthermia introduced into the body either manually or
system applicator, endoscopically. Heated fluid is circulated through the
intracorporeal applicator's tubing for localized heating to treat
malignant tumours, benign growths, or other
disease-related conditions. The applicator (also
called an interstitial applicator or probe) typically
includes a thermometry component that monitors the
temperature of the applicator during operation; it also
includes tubing, cables, and connectors that
interface with the hyperthermia system's control unit
during treatments. It is typically used in an oncology
department. This is a single-use device.S. No. Device name Intended use Risk
Class
36 Facial prosthesis An externally-applied device intended to be used as Class B
an artificial substitute for parts or sections of the face
[e.g., nose, eye(s), eye brows, upper lip] to help
restore facial appearance. The device may be
customized to meet the patient's needs and may be
held in position with magnets or screw-like implants
embedded into the patient's facial bone. It is used in
cases of severe facial disfigurement typically caused
by trauma (e.g., gunshot wounds) or major facial
cancer surgery.
37 Fixed-aperture A non-automated, x-ray beam-limiting device that is Class C
therapeutic x-ray a component of a therapeutic x-ray system and
system collimator whose opening size/length/shutter assembly is fixed.
It is used in radiation therapy applications to limit the
effects of scattered radiation and to protect the
patient by limiting or eliminating exposure to non-
target body areas during treatment. This device is
specifically designed for use with an x-ray simulation
or therapeutic x-ray system.
38 Flexible fibre optic An endoscope with a flexible inserted portion Class B
bronchoscope intended for the visual examination and treatment of
the trachea, bronchi, and lungs. It is inserted through
the mouth or nose during bronchoscopy. Anatomical
images are transmitted to the user by the device
through a fibre optic bundle. This device is
commonly used to diagnose lung infections,
pneumonia, or lung cancer, and allows physicians to
view the insides of the lungs and take biopsies and
samples of secretions. This is a
reusable device.
39 Flexible fibre optic An endoscope with a flexible inserted portion Class C
mediastinoscope intended for the visual examination and treatment of
the mediastinum (the intrapleural space located
behind the sternum). It is inserted into the body
through an artificial orifice created by an incision
made during mediastinoscopy. Anatomical images
are transmitted to the user by the device through a
fibre optic bundle. This device is commonly used to
examine structures such as lymph nodes during a
staging evaluation of lung cancer, or to establish the
diagnosis of a tumour that is localized to the
mediastinum. This is a reusable device.S. No. Device name Intended use Risk
Class
40 Flexible ultrasound An endoscope with a flexible inserted portion Class B
bronchoscope intended for the visual examination and treatment of
the trachea, bronchi, and lungs. It is inserted through
the mouth or nose during bronchoscopy. Anatomical
images are transmitted to the user by the device
typically through a fibre optic bundle or a video
system, and an ultrasound probe. The probe may be
built-in or inserted through a dedicated lumen so that
its distal tip is positioned adjacent to that of the
endoscope. It is commonly used to diagnose lung
infections, pneumonia, or lung cancer, and allows
physicians to view the insides of the lungs and take
biopsies and samples of secretions. This is a
reusable device.
41 Flexible video An endoscope with a flexible inserted portion for Class B
bronchoscope, endoscopic procedures of the airways and
reusable tracheobronchial tree (i.e., bronchoscopy). It is
inserted through the mouth or nose during
bronchoscopy. Anatomical images are transmitted to
the user by a video system with a charge-coupled
device (CCD) chip at the distal end and the images
showing on a monitor. It is commonly used to
diagnose lung infections, pneumonia, or lung cancer,
and allows physicians to view the insides of the
lungs and take biopsies and samples of secretions.
This is a reusable device.
42 General-purpose A non-electric, mechanically-powered (e.g., a spring Class C
infusion pump, mechanism) device designed for the continuous or
mechanical, intermittent infusion of medication, typically for
reusable antibiotic therapy, chemotherapy, or pain
management by intravenous (IV), subcutaneous,
intramuscular, or epidural routes. It is primarily
designed to be worn by the patient during
ambulation in the home. It may be used for patient-
controlled analgesia (PCA), and may include
mechanical indicators for flow and fluid level status.
This is a reusable device.
43 General-purpose A portable, non-electric, mechanically-powered Class C
infusion pump, device designed to be operated by healthcare
mechanical, single- professionals for dispensing a single dose of fluid
use medication (e.g., for antibiotic therapy,
chemotherapy, analgesia). It consists of an empty
reservoir intended to be filled with medication, a
flow-rate regulator and a non-sterile (sterilizable)
administration line intended to be connected to an
infusion catheter (not included) for intravenous (IV),
subcutaneous, intramuscular, or epidural
administration. It may include flow and fluid level
mechanical indicators and may be worn by the
patient in and outside of healthcare settings. This is
a single-use device.S. No. Device name Intended use Risk
Class
44 Hyperthermia A device (a probe) intended to be used exclusively to Class C
system monitor tissue or body temperature during
temperature probe hyperthermia treatments. Depending on the kind of
hyperthermia system it is used with, e.g., ultrasound,
radio-frequency (RF) or microwave, this probe is
shielded in such a way that its operation is not
affected by the energy from the hyperthermia
applicator(s) in use during the treatment. This is a
reusable device.
45 Implantable A fully-implantable device assembly intended to Class C
Vascular provide access to arteries/veins (excludes coronary
port/catheter and intracerebral circulation) for infusion (e.g.,
chemotherapeutic agents, blood transfusions) and/or
drainage (e.g., blood). It consists of: 1) a
subcutaneous chamber, with a self-sealing
puncturable septum for percutaneous insertion of a
hypodermic needle; and 2) an attached catheter
which passes into the arteries/veins.
46 Intracavitary- An assembly of electrically-powered devices Class C
circulation designed to continuously lavage body cavities (e.g.,
hyperthermia pleural cavity, peritoneal cavity, bladder lumen) with
system warmed fluids/chemotherapeutic agents to raise the
local temperature and/or enhance the effect of
drugs, typically in the treatment of malignancy. It
typically includes a water heater/cooler, fluid pump,
controls, inputs for monitoring temperature, a circuit
with heat exchanger, fluid reservoir, and tubing
connectors. Introduction/drainage catheters are
connected to the system and placed in the body
cavity.
47 Intraoperative An electrically-powered, invasive component of an Class C
gamma radiation intraoperative gamma radiation detection system
detection system intended to be introduced into the body during a
probe, reusable surgical procedure to detect and quantify gamma
radiation emitted from previously-administered
radiopharmaceuticals (e.g., localized in sentinel
lymph nodes), in conjunction with a dedicated control
unit (not included). It is typically manipulated using
surgical forceps and incorporates a crystal scintillator
and photomultiplier. This is a reusable device.S. No. Device name Intended use Risk
Class
48 Intraoperative A set of devices designed for the excitation of an Class C
tumour margin injected fluorophore (e.g., pegulicianine), and
fluorescence subsequent imaging of the illuminated area, to allow
imaging system for intraoperative detection of residual cancerous
tissue in the resection cavity following removal of the
primary specimen during surgical procedure (e.g.,
lumpectomy). It includes a probe, a handpiece with
an optical component including a digital camera
which is inserted into the cavity for image capture,
and a cable which includes a connection to the
computerised system and a fibre optic light guide.
This is a reusable device.
49 Intravascular/intrac An assembly of devices designed to circulate Class C
avitary-circulation warmed fluids or autologous blood through the
hyperthermia vasculature or cavity of a targeted anatomical area
system (e.g., peritoneal/pleural cavities, thorax, abdomen,
section of a limb) to treat cancer. It is typically
computer-controlled and consists of pumps, heat
exchanger, valves, detectors/sensors, clamps,
monitors, alarms, disposable tubing/filtration set and
oxygenator. It heats the blood/fluids to temperatures
up to 43 °C to enhance the effect of drugs [e.g., for
intraperitoneal hyperthermic chemotherapy (IPHC)]
and help destroy cancer cells.
50 Intravascular/intrac A collection of sterile devices used with an Class C
avitary-circulation intravascular/intracavitary-circulation hyperthermia
hyperthermia system for the circulation of blood/fluid between the
system set/Kit for patient and the system's extracorporeal circuit during
hyperthermic cancer therapy. It typically consists of
perfusion drains/catheters, tubing, connectors, manual clamps,
and hard or soft reservoirs; some types may include
in-line filters, an oxygenator, and temperature
sensors. This is a single-use device.
51 Microwave ablation An assembly of devices consisting of a generator Class C
system and a probe (and other accessories) intended to
generate and transmit microwave energy for
localized non-vascular soft-tissue ablation, typically
to treat tumours, hydatid cysts and/or menorrhagia.
The generator connects via a delivery cable to a
probe for delivery of microwaves to the target
tissues. It is intended to be used in percutaneous,
laparoscopic, natural orifice or open surgery
procedures to ablate tissue typically in the liver, lung,
pancreas, kidney, and uterus (e.g., endometrial
ablation).S. No. Device name Intended use Risk
Class
52 Microwave ablation A mains electricity (AC-powered) device intended to Class C
system generator generate microwave energy for localized non-
vascular soft-tissue ablation, typically to treat
tumours, hydatid cysts and/or menorrhagia
(excludes cerebral and coronary tissues). The
generator connects via a delivery cable to a probe
(not included) for delivery of microwaves to the
target tissues. It is intended to be used in
percutaneous, laparoscopic, natural orifice or open
surgery procedures to ablate tissue typically in the
liver, lung, pancreas, kidney, and uterus (e.g.,
endometrial ablation).
53 Microwave ablation A hand-held surgical instrument designed to connect Class C
system to a microwave ablation system generator to deliver
probe/microwave microwaves to a targeted operative site for localized
ablation antenna soft-tissue ablation, typically to treat tumours,
hydatid cysts and/or menorrhagia. The device is
intended to be used in percutaneous, endoscopic
[e.g., gastroscopic, laparoscopic], natural orifice or
open surgery procedures to ablate tissues (e.g.,
endometrial ablation).
54 Microwave A mains electricity (AC-powered) device assembly Class C
hyperthermia designed for controlled heating (i.e., temperatures
system above 43° Celsius) of the body using microwaves,
for the treatment of malignant or benign tumours or
other disease conditions [e.g., benign prostatic
hyperplasia (BPH), prostatitis]. It includes a
microwave generator, controls, software (e.g.,
treatment planning software) and a microwave
applicator. It is intended for both whole-body and
localized heating of tissues/organs through either
externally-mounted components or from catheter- or
probe-type applicators inserted topically,
endoscopically, or surgically.
55 Microwave A component of a microwave hyperthermia system Class C
hyperthermia designed to direct and deliver microwave energy
system applicator, used to produce a systemic or local heating effect. It
extracorporeal is typically mounted on a floor, wall, or ceiling
suspension that allows the operator to position the
microwave source from a point outside the patient's
body. The applicator assembly includes cables and
connectors that interface with the energy-generating
unit of the hyperthermia system during treatments.S. No. Device name Intended use Risk
Class
56 Microwave A component of a microwave hyperthermia system Class C
hyperthermia designed to be placed inside the body to deliver
system applicator, microwave energy to produce a systemic or local
intracorporeal heating effect. It is also referred to as an interstitial
applicator or probe and is typically a catheter-
enclosed conductor of microwave energy that is
introduced into the body either manually or
endoscopically. It typically includes a thermometry
component that monitors the temperature of the
device during operation.
57 Microwave/electros An electrically-powered component of a microwave Class C
urgical system ablation/electrosurgical system intended to generate
generator both: 1) radio-frequency (RF) electrical current; and
2) microwave energy for subsequent cutting,
coagulation, and ablation of soft tissues during an
endoscopic or open surgical procedure; it is not
dedicated to focal ablation of specific tissues. It is
not intended for inert gas electrosurgery.
58 Multi-modality A mains electricity (AC-powered) device assembly Class C
hyperthermia designed for controlled heating (i.e., temperatures
system above 43° Celsius) of the body using multiple energy
sources, for the treatment of malignant or benign
tumours, or other disease conditions (excludes
cerebral and coronary tissues). It includes a patient-
end applicator, software, and a multi-modality
generator(s)/control unit. It is intended to achieve
whole-body and localized heating of tissues using
two or more energy sources [e.g., ultrasound, radio-
frequency (RF), microwave, circulating heated fluid]
through either externally-mounted components, or
from catheter- or probe-type applicators inserted
endoscopically or surgically.
59 Photopheresis A collection of devices used as part of a Class C
system blood set photopheresis system for extracorporeal
photoimmunetherapy to treat immune disorders,
especially cutaneous T-cell lymphoma (CTCL). It
typically consists of tubing (patient and fluid lines),
fluid/blood component bags, a dedicated centrifuge
bowl, a photoactivation chamber, connectors, and
clamps. It conducts blood from the patient to the
system's main unit, aids in blood processing, and
returns leukocyte-enriched and untreated
components of the blood after irradiation. This is a
sterile, single-use device.
60 Photopheresis An assembly of ultraviolet A (UVA)-emitting tubular Class C
system lamp strip lights that is an exchangeable component of a
assembly photopheresis system, and used to irradiate blood
components during extracorporeal
photoimmunetherapy to treat immune disorders,
especially cutaneous T-cell lymphoma (CTCL).S. No. Device name Intended use Risk
Class
61 Polymer-metal A non-bioabsorbable, expandable, tubular device Class C
oesophageal stent intended to be implanted into the oesophagus to
maintain luminal patency in strictures and prevent
tumour in-growth. It may also be intended to seal
oesophageal fistulas, reduce acute bleeding from
oesophageal varices, and/or to treat other lesions
causing oesophageal leakage (e.g., anastomotic). It
is typically expanded in situ (e.g., self-expands) and
disposable devices intended to assist implantation
may be included.
62 Radiation therapy An automated device that is typically mounted on the Class C
digital imager gantry of a linear accelerator and intended to
produce digital images of x-rayed anatomical
landmarks to guide radiation treatment (e.g.,
tracking/targeting tumours). The device may be a
digital imaging panel (e.g., of silicon) on robotic
arms; it may also have an x-ray source to generate
higher quality images.
63 Real-time position An assembly of electronic devices designed to track Class C
management the respiratory pattern of a patient by means of
respiratory gating optical technology to correlate tumour position with
system, the respiratory cycle during radiation treatment
optical/Respiratory planning, radiotherapy, computed tomography (CT)
gating system, imaging, or other radiation procedures. It provides
radiation procedure real-time position management (RPM) and involves
optical-based tracking (e.g., video, infrared, laser) of
the respiratory cycle to enable irradiation control
during the procedure. It may include a tracking
camera connected to a dedicated personal computer
workstation and a reflective chest wall/abdominal
marker.
64 Robotic Guidance It is an accessory to an imaging system (CT, CT- Class B
system for image PET) intended for the spatial positioning and
Guided procedures orientation of an instrument guide. A surgeon then
manually advances one or more instruments for
percutaneous image guided interventional
procedures through the instrument guide. The device
is not intended to make any contact with the patient.
65 Scalp cooling An assembly of electrically-powered devices Class B
system, hair loss intended to reduce scalp hair loss associated with
intravenous chemotherapy treatment by cooling the
scalp to cause vasoconstriction and reduction of
chemotherapy drug uptake by the follicular cells. It
consists of a control unit which pumps a cooling
agent to a head-worn cap containing coolant
channels and temperature monitoring sensors. An
insulating cap (e.g., neoprene) may be worn over the
cooling cap to secure it and prevent condensation.S. No. Device name Intended use Risk
Class
66 Stereotactic A set of devices that are designed to uses very Class D
radiosurgery precise beams of gamma rays to treat an area of
system for central disease (lesion) or growth (tumor), especially in the
nervous system brain, upper spine and in certain cases, vascular
(CNS) abnormalities.
67 Teletherapy A device that is a component of a teletherapy Class B
radionuclide radionuclide system (commonly known as a cobalt
system table, therapy machine) and that is a
powered powered/programmable table specifically designed
to position and support a patient during treatments
administered using a therapeutic radionuclide
teletherapy system (e.g., a Cobalt-60 teletherapy
system). It has electronic and/or software controls for
table top height and positioning. It can be a
stationary or mobile unit, or incorporated as an
integral component of a radionuclide teletherapy
system or gantry configuration.
68 Teletherapy A stationary assembly of computer-based devices Class C
radionuclide designed to deliver a therapeutic radiation dose to
system, an anatomical region from a single external radiation
conventional/Cobal beam produced by a radionuclide source, typically to
t therapy machine treat malignant tumours; it does not provide image-
guided radiation therapy (IGRT) functionality during
treatment delivery.
69 Telethermographic A telethermographic system intended for adjunctive Class A
system diagnostic screening for detection of breast cancer
or other uses is an electrically powered device with a
detector that is intended to measure, without
touching the patient's skin, the self-emanating
infrared radiation that reveals the temperature
variations of the surface of the body. This generic
type of device may include signal analysis and
display equipment, patient and equipment supports,
component parts, and accessories.
70 Therapeutic An assembly of electrically-powered devices Class C
oncological/gynaec designed to treat solid tumours of hard (bone) and/or
ological ultrasound soft tissue [e.g., liver, kidney, breast, prostate] and/or
system (High gynaecological disorders (e.g., uterine fibroid,
intensity focused adenomyosis) through noninvasive or non-surgically
ultrasound (HIFU) invasive localized application of high intensity
ablation system) focused ultrasound (HIFU) or high intensity
therapeutic ultrasound (HITU) intended to gradually
denature/ablate tissue lesions. Optimal patient
positioning is achieved using an ultrasound scanner
or MRI system.S. No. Device name Intended use Risk
Class
71 Tumour-therapy A mains electricity (AC-powered) device assembly Class C
radio-frequency designed for controlled heating (i.e., temperatures
hyperthermia around 43° Celsius) of the body using radio-
system frequency (RF) energy, for the treatment of
malignant or benign tumours, or other disease
conditions; it is not intended for direct tissue ablation.
It is intended for both whole-body and localized
heating of tissues/organs through either externally-
mounted components or from catheter- or probe-
type applicators inserted topically, endoscopically, or
surgically.
72 Tumour-therapy A component of a radio-frequency (RF) hyperthermia Class C
radio-frequency system designed to be placed in the body to deliver
hyperthermia radio-frequency (RF) energy to produce a systemic
system applicator, or local heating effect for the treatment of malignant
intracorporeal or benign tumours, or other disease conditions. It is
also referred to as an interstitial applicator or probe
and is typically a catheter-enclosed conductor of RF
energy that is introduced into the body either
manually or endoscopically. This is a single use
device.
73 Ultrasonic An assembly of devices designed to produce and Class C
hyperthermia control the delivery of high heat (i.e., temperatures
system/Ultrasonic greater than 43 deg Celsius) to the body using
ablation system ultrasonic energy for the intracorporeal or
extracorporeal treatment of malignant or benign
tumours, or other disease conditions. Energy
delivered to the patient is from either an externally-
mounted transducer or a transducer-containing
catheter or probe used topically or inserted
endoscopically or surgically. It is not intended for
physiotherapy applications.
74 Ultrasound An ultrasound (US) transducer assembly that is a Class C
hyperthermia component of an ultrasound hyperthermia system
system transducer, used to induce systemic or local body heating of
extracorporeal sufficient magnitude to create a targeted therapeutic
effect. It is mounted within the gantry or housing of
the hyperthermia system or mounted on a floor, wall,
or ceiling suspension that allows the operator to
position the transducer assembly external to the
patient during treatment.
75 Ultraviolet An assembly of devices used for extracorporeal Class C
Extracorporeal photoimmunetherapy to treat immune disorders,
Photopheresis especially cutaneous T-cell lymphoma (CTCL). It
system irradiates the leukocyte-rich fraction of peripheral
blood by UVA radiation extracorporeally and returns
back the treated and untreated blood to the patient.
This system may or may not use a UV-active drug
(either ingested by patient or injected into the
leukocyte-rich fraction of the extracted peripheral
blood)Name of Category:
Class A (non-sterile and non-
measuring) medical devices
Total No. of Devices:
803List of Class A (Non-sterile and non-measuring) medical devices (other than
In-vitro diagnostic (IVD) medical devices)
S.No. Device Name Intended Use
1 Abdominal support/belt/binders, Intended to hold abdominal muscles together to
reusable relieve pain and increase circulation at surgical site
to promote healing and decrease swelling. May also
make physical activity more comfortable.
2 Abdominal support/belt/binders, Intended to hold abdominal muscles together to
single use relieve pain and increase circulation at surgical site
to promote healing and decrease swelling.
3 Abrasive polishing agent A substance, or combination of abrasive substances
(e.g. silica pumice), intended to be used for cleaning
the accessible surfaces of the teeth by polishing. It
does not contain medication and used by dental
professionals.
4 Absorbent cotton wool Intended to used for applying medication to, or
absorbing small amounts of body fluids
5 Accupressure calf band Intended to wear around the calf to apply pressure
to an acupressure point to relieve low back pain,
including sciatica and piriformis syndrome.
6 Accupressure wristband Intended for the application of pressure to the Nei-
kuan (P6) acupressure point on the wrist, the area
identified to help relieve the sensation of nausea.
7 Acoustic chamber for audiometric Intended for use in conducting diagnostic hearing
testing evaluations, while eliminating sound reflections and
providing isolation from outside sounds.
8 Acoustic Stethoscope A mechanical listening device used for listening to
sounds from the heart and lungs and their qualitative
assessment.
9 Activated-medium surgical warming A non-sterile device intended to help prevent a
blanket patient from cooling prior to, during, and after a
surgical intervention by serving as a heat-generating
cover.
10 Acupressure applicator, reusable Applied to the skin without insertion into the body to
apply pressure and/or friction to acupressure points.
11 Acupressure applicator, single-use To be used for acupressure treatment at home by
applying non-invasive pressure to acupuncture
points. Applied to the skin without insertion into the
body.
12 Acupuncture unit, home use It is intended to provide mild and temporary
stimulation of accupressure points resulting in
improvement of energy flow and overall vitality.S.No. Device Name Intended Use
13 Adaptor, light source Intended to permit the connection of the devices that
together deliver light to a work field from a light
source.
14 Adaptor, luer Adapters which connect or stopper enteral feeding
tubes.
15 Adhesive felt pad Intended to offload pressure from ulcer areas,
recurrent plantar ulcers, calluses and corns
16 Adhesive plaster (Zinc oxide It is intended to secure dressings and for strapping
adhesive plaster)/Tape on intact skin.
17 Adhesive strip A flexible strip (of fabric, plastic, paper, or other
material) coated on one side with a pressure-
sensitive adhesive, typically used to cover or
approximate the edges of superficial wounds or fix
dressings to skin. The device may include an
adhesive pad and have qualities such as waterproof.
18 Adhesive tape remover Help reduce pain and ease removal of medical
adhesives used in stoma care products, dressings
and other medical appliances from the skin surface
19 Adult Diaper/Under Pad Intended to be used by an incontinent patient's for
absorbing excreta (e.g, urine, etc.). It may be
intended for home-use or/and hospital settings.
20 Aerosol adhesive for compression A sticky substance that is applied on the skin to
garments anchor compression garments in place.
21 Aerosol delivery tubing A flexible tube used in conjunction with an oxygen
mask, endotracheal (ET) tube, humidifier, or
nebulizer, intended for the delivery of aerosolized
humidification, typically oxygen enriched.
22 Air cushion/Pressure relief cushions Intended to relieve pressure on an affected area
when a person has hemorrhoids or when he has
undergone surgery in the back or buttock
area/prevention of pressure sores/ulcers in patients
23 Airway device cleaning A hand-held device intended to be used to clean an
utensil in situ airway device (not disinfection). It can also be
used to clean an airway device ex situ (i.e., once it
has been removed from the patient).
24 Airway protection face mask Intended to provide respiratory protectionS.No. Device Name Intended Use
25 Airway tube forceps, reusable Used for grasping a tube for its insertion and/or
extraction into/from the airways, or for grasping
obstructive objects for their removal from the
airways.
26 Alarm, bed occupancy Bed Floor Mat/Crash Mat Alarm/Alert Patient
Movement
27 Allergy testing adhesive strip, A band of adhesive material designed to be used for
epicutaneous epicutaneous allergy testing.
28 Alternating-pressure bed mattress A pad or thin mattress, usually full-body length,
overlay, reusable which is placed on top of a bed mattress and
designed with parallel chambers that are alternately
filled with forced-air to actively change an occupant's
bed contact points, typically to relieve pressure
points for comfort and to prevent pressure sores. It
is commonly used for elderly immobilized (especially
in cases of decubitus ulcers), patients with
disabilities, or patients with low body fat. This is a
reusable device.
29 Alternating-pressure bed mattress A pad or thin mattress, usually full-body length,
overlay, single-use which is placed on top of a bed mattress and
designed with parallel chambers that are alternately
filled with forced-air to actively change an occupant's
bed contact points, typically to relieve pressure
points for comfort and to prevent pressure sores. It
is commonly used for elderly immobilized (especially
in cases of decubitus ulcers), patients with
disabilities, or patients with low body fat. This is a
single use device.
30 Alternating-pressure bed mattress An alternating pressure system designed to be used
system on top of a bed to provide therapeutic or protective
effect.
31 Amsler grid Intended to rapidly detect central and paracentral
irregularities in the visual field.
32 Anaesthesia catheter Luer connector Intended to create a mechanical union between an
anaesthesia catheter and an external device
33 Anaesthesia depth simulator intended to simulate the electroencephalography
(EEG) signals of an unconscious patient
34 Anaesthesia instrument It is intended as a support for Anaesthesia
table instruments used during general anaesthesia
surgical procedures.S.No. Device Name Intended Use
35 Anaesthesia mask stabilizer A device intended to secure an anaesthesia mask
on the face of a patient typically by providing
anchorage for the fixation of the mask's headstrap.
36 Anaesthesia mask stabilizer, single- Accessory to anesthesia face mask to assist in
use locating the mask headgear (strap) to the mask.
37 Anaesthesia system leakage tester A device intended to test an anaesthesia system for
leakage.
38 Anaesthesia tube holder The intended purpose for this device is for holding
and supporting respiration tubing and breathing
circuits connected to a patient, to prevent
disconnection.
39 Anaesthesia warmer A device intended to warm the anaesthetic solutions
prior to it being administered to a patient for
anaesthesia.
40 Anaesthetic gas scavenging terminal A device intended to function as an outlet assembly
unit to which the operator can connect/disconnect an
anaesthetic gas scavenging system (AGSS).
41 Analytical non- scalp cutaneous lead Intended to conduct electrical signals between a skin
electrode(s) or needle electrode(s) [electrode not
included] and a device designed for
electrophysiological recording/monitoring [e.g.,
electromyography (EMG), evoked potentials (EP),
bioelectrical impedance].
42 Analytical non-scalp cutaneous Electrical conductor designed to be attached to the
electrode skin surface of a patient outside of the hair line (i.e.,
non-scalp) to conduct electrical signals to a parent
device for electrophysiological recording/monitoring.
43 Analytical non-scalp cutaneous Intended to conduct electrical signals between a skin
lead electrode(s) or needle electrode(s) [electrode not
included] and a device designed for
electrophysiological recording/monitoring [e.g.,
electromyography (EMG),
evoked potentials (EP), bioelectrical impedance].
44 Anatomical training model A 3-D printed patient specific model of an organ
(e.g., heart, kidney, lung) or bone(s) intended to be
used to assist peri-operative anatomical visualisation
and surgical treatment planning. It is created using
3-D Printing processes based on patient medical
images.
45 Anesthesia face mask, reusable A device designed to be placed over a patient's nose
and/or mouth to administer anaesthetic gases to the
upper airway.S.No. Device Name Intended Use
46 Anesthesia face mask, single use A device designed to be placed over a patient's nose
and/or mouth to administer anaesthetic gases to the
upper airway.
47 Ankle binder, reusable A strip or roll of fabric or plastic material designed to
be wrapped around the ankle to help stabilize and
support the joint.
48 Ankle cap Intended to provide mild compression & support to
the ankle joint and to manage ankle pain and
inflammation.
49 Ankle sleeves/brace Intended as the external supports to limit certain
motions, such as plantar flexion/inversion and
manage postoperative/posttraumatic pain
50 Ankle traction belt Intended to immobilize the ankle and adjoining joints
after injury / surgery to support fast healing and
prevents further damage and also helps to decrease
pain, spasms and swelling.
51 Ankle/foot orthosis A prefabricated (non-customized) externally applied
and wearable appliance or apparatus intended to
encompass the ankle joint, or the ankle and foot, to
support, align, prevent, or correct orthopaedic
deformities/injuries or to improve function of the
ankle and/or foot through actions such as alignment,
hinge-support, or dorsiflexion assistance.
52 Ankle/foot orthosis A prefabricated externally applied and wearable
appliance or apparatus intended to offload and
redistribute foot pressures that affect pedal
circulation to improve blood flow and help heal
diabetic foot ulcers or postsurgical wounds.
53 Anomaloscope Intended to test a patient for abnormal red/green
colour vision by differentiating the red/green colour
vision defects.
54 Anterior chamber physical simulator Designed to mimic the fluid dynamics in the anterior
chamber of the eye during priming/calibration of a
phacoemulsification system irrigation/aspiration
pump.
55 Anterior wedge footwear/Off loading Intended for offloading the pressure from forefoot to
shoes heel after correction of conditions such as Hallux
Valgus, Hammer Toes, Tailors Bunions and Ulcers
of the forefoot
56 Antimicrobial postsurgical brassiere Intended to support and/or contour the breast(s) or
hold a dressing in place after surgical intervention
(e.g. thoracic surgery, mastectomy, lumpectomy).
May be used to prevent the formation of oedema
and to support venous return and lymphatic
drainage.S.No. Device Name Intended Use
57 Antimicrobial postsurgical female It is intended for use during medical treatment (e.g.,
underpants chemotherapy) or be used to protect the skin
following treatment with a medication (e.g. ointment,
cream).
58 Anti-shock body support/Garment Intended to prevent excessive blood loss and
prevent post partum haemorrhage complications.
59 Anti-tremor gyroscopic orthotic glove A battery-powered device designed to be worn on
the hand/forearm of a patient with hand tremors
[e.g., due to Parkinson’s disease, Essential tremor
(ET)] to reduce tremors and facilitate activities of
daily living using the hand. It is in the form of a glove
with forearm sleeve and built-in gyroscopes which
generate tremor-countering forces to promote hand
stabilization.
60 Arm board pad It is intended to provide support to the patient's arm
during prolonged surgeries.
61 Arm board, pediatric This medical device is intended to immobilize and
hold steady infants’ limbs when securing intravenous
lines.
62 Arm prosthesis socket A device that fits over the terminal end of a residual
upper limb and serves as an interface between the
limb and an artificial replacement arm segment
(prosthesis).
63 Arm prosthesis, pediatric Artificial hand or arm prosthesis for physically
disabled pediatric patients.
64 Arm sling Intended to immobilize the arm, by means of a fabric
band suspended from around the neck.
65 Arm/leg procedure positioner padded To protect the patient's foot/leg in stirrups.
strap
66 Artificial airway stylet A device intended for insertion within the lumen of
an artificial airway tube to stiffen and/or maintain the
shape of the tube to facilitate intubation.
67 Assistive ergonomic chair mobility Intended for use as a support to an assistive
base ergonomic chair used by a healthcare provider/carer
to provide mobility for a disabled (often paediatric)
patient.S.No. Device Name Intended Use
68 Assistive ergonomic chair, An electrically-powered device intended to support
electrically-adjusted and position a patient (disabled and/or discomforted)
in a sitting posture while performing activities of daily
living, including work-related activities and to provide
improved personal body posture and/or to help
prevent/reduce physical problems associated with
poor mobility or sedentary lifestyle. It is not a
wheelchair
69 Assistive foot-propelled bicycle A therapy bike designed for children and teenagers
with neuromuscular diseases permitting independent
mobility, assisting physiotherapist treatments,
providing training for support and balance reactions
as well as movement coordination.
70 Assistive gripping/twisting tool, The devices are handheld grips with attached
reusable wristbands intended for stimulation of the sensory
neuronal network (hand/fingers) as part of therapies
for patients suffering from neurodeneration such as
ASD, ADHD and Parkinson's, or other nervous
issues.
71 Assistive shoes/boots It is a shoe attachment that is primarily intended to
assist people with Parkinson’s to overcome a
symptom called Freezing of Gait (FOG) through
visual cueing by providing visual cues in the form of
laser lines. It can act as an intervention for falls
prevention in the Parkinson’s population.
72 Atomizer A device that is intended to provide liquid medication
in aerosolized form into the air that a patient will
breathe.
73 Attention assistive training device A device designed to be used by a person with a
disorder to develop their attention ability to select,
focus, control and inhibit.
74 Automated perimeter Intended to be used to measure the visual field of
the eye.
75 Back Support/Brace Intended to prevent unnecessary movements and
pain that may further damage the back and to help
in alignment of spine and strengthening of back
muscles.
76 Bagolini lens Intended to determine harmonious/anomalous
retinal correspondence.
77 Balance Board Intended to train patient with difficulties in balance
(proprioreception) ( e.g. a paraplegic or a stroke
patient)S.No. Device Name Intended Use
78 Balance/mobility management This device uses sensors to determine the centre of
system pressure and postural sway of an individual during
standing for balance management.
79 Bandage scissors, reusable Heavy scissors for cutting pads, plaster and plastic
rail associations.
80 Bar dental precision attachment It connects removable partial dentures to fixed
bridgework under a male/female locking mechanism.
81 Basket stretcher Intended to transfer patients in emergency situations
such as in the mountains, and marine offshore
application.
82 Bed board A flat, stiff device designed to increase the firmness
of a hospital bed's mattress to provide an
appropriate rest surface for the user typically with
spinal problems.
83 Bed exit monitor, fall prevention Intended to be placed under mattress and used to
indicate by an alarm or other signal when a patient
attempts to leave the bed.
84 Bed traction frame Intended to provide overhead support framing for
hospital beds to assist in the treatment and
movement of bed patients
85 Bedrail pad Intended to protect the patient from coming into
contact with the bedrails and inadvertently hurting or
injuring themselves.
86 Bicycle exerciser Device is used by patients in a physical therapy
setting under the direction of a medical professional
for passive, assisted & active training of upper and
low limbs during rehabilitation, to improve motor
function.
87 Binocular loupes It is intended for viewing details of objects with some
magnification during ophthalmic/dental and other
examinations and surgeries
88 Biofeedback system for rehabilitation A system, comprising of wearable motion capture
devices that allows patients with upper and lower
extremity movement dysfunction to undertake
intensive practice of single and multi-joints using
movement biofeedback. The system detects
movement and provides this as feedback to the
patient. This does not display a quantifiable property
in measuring units.
89 Birthing bath Intended to be filled with heated water for use before
and/or during child birth and to provide a
comfortable environment for the expecting mother
prior to birth.
90 Birthing bed/table, non-powered Intended to be used as a support surface during
labor and delivery.S.No. Device Name Intended Use
91 Birthing bed/table, powered Intended to be used as a support surface during
labor and delivery.
92 Bite block, dental A non-sterile device inserted into a patient's mouth
for the prevention of oral tissue damage (e.g., the
teeth, lips, tongue and buccal mucosa) and to allow
them to bite down on for greater comfort during a
dental procedure. This is a reusable device.
93 Bite block, endoscopy A single use accessory used to protect both the
patient and the endoscope, when an endoscope is
inserted into a patients mouth for a procedure. It
may also be used during other treatments such as
intubation of a tracheal tube.
94 Bite block, radiotherapy Bite Blocks are devices which are used to
reproducibly position the mouth, tongue or lips
during radiotherapy treatment of the head and neck.
95 Bite registration rim wax A dental material (modelling wax) with or without
reinforcing foils (metal, polymer) for registration of
jaw relation (making bite rims).
96 Bite relief pad Intended to help relieve pain or discomfort after
orthodontic treatment by placement between the
upper and lower sets of teeth and bitten down on.
97 Blood/body fluid solidifier A solidifier substance is intended to be used to
absorb and solidify blood and/or other body fluids
collected in surgical suction canisters. The
substance is often added to the bottle/canister
before or after collection of the fluid.
98 Bobath table Intended for postural exercises, rolling, turning and
balance training of patients with loss of sensation or
poor balance and other neurological conditions such
as stroke, head injury and orthopedic indications
99 Body arch traction table Intended to support the body of a patient and
provide traction for the back muscles and spine by
flexing the patient into a reverse supine body arch
100 Body waste receptacle Intended for medical purposes that is not attached to
the body and that is used to collect the body wastes
of a bed patient.
101 Brachytherapy radionuclide Intended to mimic the functional/physical
phantom, test object characteristics of normal or diseased human organs
during performance evaluations of brachytherapy
systemS.No. Device Name Intended Use
102 Breast binder A non-sterile device intended to be applied to the
breast or breasts for soft tissue support or securing
a dressing in place after surgical procedures.
103 Breast pad Used to absorb excess milk and protect the breast
during nursing.
104 Breathing circuit bag/Reservoir bag A device intended to store breathing gas during the
respiratory cycle.
105 Breathing circuit condenser Intended to be integrated within the expiratory limb
of a breathing circuit to remove excess moisture
through cooling and condensing, whilst also
reheating the dried gases to an appropriate
machine-compatible temperature.
106 Breathing circuit dryer A device that is used for the purpose of drying
breathing circuit equipment that have been washed
in order to prevent bacteria growth and deterioration.
107 Breathing mouthpiece A device intended to be inserted into a patient's
mouth to facilitate access to the respiratory system.
108 Cable-controlled hand prosthesis Intended as an artificial hand for physically disabled
persons, whose movement can be controlled by a
cable
109 Camera cover Provide an infection-control protective barrier for
dental intra-oral camera
110 Camera for dental use Intended to be used to record that location of posts
and or abutments in a lab model or the mouth
allowing for a dental treatment plan to be produced
during dental implant planning.
111 Camera for medical applications A camera to be used with microscopes, colposcopes
and on endoscopic procedures.
112 Canalith repositioning procedure A device intended to be occupied by a patient and
chair, manual manually operated by a healthcare professional to
facilitate therapeutic physical manoeuvres of the
patient’s head and trunk (accelerations and
decelerations in a multiaxial plan) to treat balance
disorders [e.g., benign paroxysmal positional vertigo
(BPPV), canalithiasis] caused by displaced canaliths
(otoconia) in the inner ear of the patient.
113 Capnography oxygen mask A device intended to be placed over the nose and
mouth to deliver oxygen (O2) to a patient's airway
and to sample exhaled respiratory gases for
monitoring the patient’s ventilatory status.S.No. Device Name Intended Use
114 Capnography sampling The device is intended for sampling CO2 and use
adaptor with monitors enabled with capnography technology
.
115 Cardiac compression board A flat, rigid device that is placed under a patient to
act as a support during cardiopulmonary
resuscitation.
116 Cardiopulmonary resuscitation mask A flexible, form-shaped device that is placed over a
patient's mouth to administer "mouth-to-mask"
exhaled air from the user to the patient during
cardiopulmonary resuscitation (CPR).
117 Cardiopulmonary resuscitation A non-sterile device that consists of a mouthpiece
mouthpiece/cover with an integrated face/body covering sheet
intended to be placed over a patient during
cardiopulmonary resuscitation (CPR) to prevent
cross-contamination between patient and CPR
administrator. This is a single-use device.
118 Cast boot/shoes A boot-like cover for a foot enclosed in a leg cast or
bulky bandages intended to support postsurgical
healing, injury/trauma care or any situation that
requires a pressure off-load of the foot.
119 Cast removal protective tape To be placed between a cast stockinette and the
lining of a cast, along the line where subsequent
cast cutting is intended to occur during cast removal,
to prevent cuts and burns to the skin caused by the
cast cutter/saw.
120 Cast stockinette Intended to be used with casting material to provide
under-cast padding and cushioning.
121 Cast walking heel A rubber device designed to be attached to or
incorporated into a cast to support the patient while
walking.
122 Cerebral Cavernous Malformations Intended for stimulation of the eye for treatment of
(CAM) vision stimulator lazy/ambyopic eye
123 Cerebral Palsy (CP) walker Intended as a walking aid for patients affected by
cerebral palsy, for postoperative rehabilitation, polio,
and other neurodevelopmental conditions
124 Cervical cytology scraper, reusable Intended to scrape and retrieve cytological material
from the surface of the cervix (neck of the uterus) or
vaginal area for pathological examination and
diagnosis, often for the detection of cervical cancer.S.No. Device Name Intended Use
125 Cervical pillow Intended to provide support to people who have
trouble keeping their spine straight and management
of neck/cervical pain
126 Cervical spine collar Intended to support or immobilize the cervical spine
to treat deformities, fractures, sprains, or strains
(often to treat whiplash resulting from an
automobile accident).
127 Cervical traction head holder/head Intended to be used with cervical traction kit to halt
halter the head for physical support.
128 Cervical traction kit (with/without Intended for traction of cervical region in conditions
weights) such as neck or back pain, post surgery
rehabilitation, reducing neck pressure, etc.
129 Cervical traction spreader bar/ Intended to serve as a component of a traction kit to
Spreader bar relieve pressure by stretching the musculature and
connective tissue components of the cervical spine.
130 Cervicothoracic spine orthosis Intended to support or immobilize deformities,
fractures, sprains, or strains of the cervicothoracic
spine.
131 Cervicothoracolumbosacral spine Intended to encompass the
orthosis cervicothoracolumbosacral spine region of the neck
and trunk.
132 Chair cushion, pediatric use A supportive seat shell designed for use with a
disabled child to allow them to sit independently on a
chair/swing/shopping trolley
133 Chair, flotation therapy Intended to aid in the prevention of pressure injuries
as a result of reduced mobility and extended sitting
postures.
134 Chemotherapy spill clean-up kit Intended to safely clean and dispose of
Chemotherapy drug spills.
135 Chest stand Intended to provide a stable and adjustable platform
to position patients for accurate and high-quality
chest/full body X-ray examinations.
136 Chest/Limb Restrainer Intended to stop or limit a patient's movement
137 Cholera bed Intended as a physical suppport for severely ill and
weak patients including those suffering from cholera
138 Circulating-fluid thermal therapy Designed to provide extended cold therapy to assist
system in a variety of applications as directed by a medical
professional. It is designed not to be applied directly
to the skin and is to be used as part of recovery from
surgery either in the hospital setting or at home.S.No. Device Name Intended Use
139 Clamp for rubber dam A dental device with a buccal and lingual wing, or
flange, used to anchor a rubber dam down to the
cervical region of an exposed tooth.
140 Clavicle support/brace/belt Intended to support and limit the movement of
clavicle bone in case of injury, fracture, post surgery,
etc.
141 Cognitive test equipment Evaluation and training in stereognosis, form
constancy, position in space, shape recognition and
sequencing as well as teaching compensatory
techniques for loss of visual field.
142 Cold compression therapy cervical Intended to facilitate, through cooling and
spine collar compression, the treatment of a variety of conditions
resulting from injury/surgery to the neck region (e.g.,
inflammation, stiffness, whiplash).
143 Cold/cool therapy gel Intended for localized topical skin application to
provide a cooling effect for underlying muscles/joints
to reduce pain and swelling.
144 Collar and cuff arm sling Intended to immobilize forearm, elbow, humerus or
shoulder injuries.
145 Colour discrimination non- A non-prescription ophthalmic device intended for
prescription spectacles use by people with color blindness to improve color
discrimination and blocks UVA and UVB radiation
from sunlight.
146 Colour discrimination tester Intended to test a person's ability to differentiate
between colours.
147 Colour-discrimination eye chart Intended for testing colour vision.
148 Compression bandage: two Intended for management/prevention of venous
component system insufficiency, chronic oedema, venous ulcers, etc.
149 Compression/pressure sock/stocking Intended to assist in wearing/removing of medical
applicator compression stockings.
150 Compression/pressure tubular To tightly fit over and apply compression/pressure
garment (i.e., graduated or even-force) to a part of a limb,
typically for the treatment/prevention of a disorder(s)
of circulation [e.g., venous insufficiency, deep vein
thrombosis (DVT)], to control scarring, and/or to
manage lymphoedema.S.No. Device Name Intended Use
151 Conductive abrasive gel for skin Designed to reduce the resistance (impedance) and
preparation defatting the skin in preparation for
electrophysiological examinations:
electroencephalography (EEG), long-term EEG
monitoring, polysomnography (PSG), evoked
potentials (EP), stress test ECG, ECG monitoring by
Holter in clinics, hospitals, diagnostic centers
152 Conductive electrode gel/paste Intended to reduce resistance between skin and
(adhesive/non-adhesive) electrodes during examinations such as ECG, EEG,
EMG
153 Congenital hip dislocation abduction Intended to stabilize the hips of a young child with
splint dislocated hips in an abducted position (away from
the midline).
154 Contact lens inserter/remover Intended to insert and remove contact lenses from
the eye.
155 Continuous glucose monitor Intended to analyze and correlate retrospective data
retrospective data analysis software from a continuous glucose monitoring device.
156 Controlled ankle motion (CAM) Intended for preventing/limiting foot/ankle movement
walker in cases of serious sprain, surgery or removal of
cast
157 Core-body mechanical weight Intended to enable a patient with a lumbar spine
exerciser injury to perform controlled extension, contraction,
and/or twisting movements of the lumbar/thoracic
spine back region and the abdomen, for testing and
rehabilitation.
158 Corn/callus dressing, reusable The device is intended to offer symptomatic relief of
physical foot disorders and similar conditions, by
providing a mechanical barrier which relieves the
effects of pressure and friction and or support.
159 Corn/callus dressing, single use A non-sterile adhesive dressing intended for
protection and/or relief of corns or calluses
(hardened areas of skin on the feet or toes).
160 Cotton and rubber elastic bandage It is and elasticated device intended to be worn on
limbs for managements of sprains, strains and
painful joints on intact skin.
161 Cotton crepe bandage It is intended to be worn on limbs for managements
of sprains, strains and painful joints on intact skin.
162 Cottonoid pad A device that is placed next to the parotid gland in
order to absorb the saliva that is being secreted.
This aids in dental procedures as it helps maintain a
working field dry.S.No. Device Name Intended Use
163 Cover for thermomete probe It acts as a physical barrier between the patient and
an in-the-ear thermometer to prevent cross-
contamination between patients.
164 Cover, dental To cover and protect a dental handpiece during
dental procedures and prevent cross-transmission of
infection between patients.
165 CPAP/BPAP chin strap, reusable A device in the form of a strap or band intended to
be fastened around a patient’s head (vertically from
chin to crown) during positive airway pressure (PAP)
therapy to control mouth air leaks by gently holding
the mouth closed.
166 CPAP/BPAP chin strap,single use A device in the form of a strap or band intended to
be fastened around a patient’s head (vertically from
chin to crown) during positive airway pressure (PAP)
therapy to control mouth air leaks by gently holding
the mouth closed.
167 Cranial orthosis, pediatric A patient-matched helmet-like device, intended to be
worn on the head of an infant with an abnormal head
shape (e.g. due to plagiocephaly, brachycephaly) to
improve cranial symmetry/shape during growth over
a period of months.
168 Crash cart/Emergency recovery Intended for use in hospitals for transportation and
trolley dispensing of emergency medication/ equipment at
the site of a medical/surgical emergency for life
support protocols.
169 Crutches Intended to help transfer of load from the legs to the
upper body of people who cannot use their legs to
fully support the weight of their body due to
temporary or permanent disabilities.
170 CT phantom, test object Intended to establish, validate, and provide for
routine and periodic verification of patient imaging
CT system performance consistent with
internationally recognized standard.
171 Custom-made anatomy model A model of the bone of a specific patient intended for
use to facilitate accurate preoperative planning and
introperative placement of a device during
orthopaedic surgical procedures.
172 Cytotoxic waste receptacle Intended to safely deposit, collect and store
cytotoxic materials (e.g.,
chemotherapy/antineoplastic drugs).
173 Dappen dish, reusable Intended to hold and mix dental materials.
174 Dappen dish, single-use Used to hold and knead dental materials.S.No. Device Name Intended Use
175 Denis Brown splint Intended to immobilize the foot, particularly on
young children with tibial torsion (excessive rotation
of the lower leg) or club foot.
176 Dental abrasive disk guard A dental device intended to be fitted around an
abrasive disk when rotating at high-speed to protect
tissues not intended to come in contact with the
abrasive disk.
177 Dental abrasive disk, reusable Intended for use in contouring, finishing, and
polishing dental restorations.
178 Dental abrasive disk, single-use Intended for use in contouring, finishing, and
polishing dental restorations.
179 Dental abrasive strip, reusable It is intended to be used for cleanup, polish or finish
dental crowns and bridges after cementation of
crowns, veneers, bridges, inlays or onlays.
180 Dental abrasive strip, single-use It is intended to be used for cleanup, polish or finish
dental crowns and bridges after cementation of
crowns, veneers, bridges, inlays or onlays.
181 Dental amalgam mixer This is a dental benchtop amalgamator that is
intended to mix by vibration/shaking, encapsulated
materials to be used for dental restorative
procedures in the mouth.
182 Dental articulation liquid A range of pressure indicating material used to
locate areas of denture or removable dental device
discomfort in the patients mouth. Used for seating
crowns, bridges, full dentures, immediate dentures
and partial dentures.
183 Dental articulation paper Intended for marking areas of contact between
opposite teeth, restorations or appliances.
184 Dental automated x-ray film A mains electricity (AC-powered) automated dental
processor x-ray film processor designed to be used in the
dental practice for the rapid processing of films.
185 Dental cheek retractor, home-use This is a hands-free, self-retaining frame that is
intended for home use by a patient to retract the
lips/cheeks to facilitate viewing of the teeth.
186 Dental cotton roll It is intended as an absorbent, hard-packed cylinder
(a roll) that is used as a saliva absorber from the oral
cavity during dental procedures. It may also be used
as a packing between the lip/cheek and the gum to
give better examination/operative exposure.
187 Dental cuspidor This is a vessel, e.g. a round bow, into which the
patient may expectorate during and after dental
procedures.S.No. Device Name Intended Use
188 Dental floss It is a tape/thread-like device intended for removing
plaque, food debris, etc. from between the teeth
and aid in prevention of dental caries
189 Dental implant abutment analog A rod-like device intended to be used as a copy of a
dental abutment, for a dental laboratory working
model, to confirm the orientation/position of the final
dental abutment placement; it may be used during a
scanning procedure
190 Dental implant abutment impression A device intended to be placed intraorally on the
cap abutment head of a dental implant during dental
impression procedures, to facilitate the removal of
the impression material after setting and to ensure
the position of the implant in order to transfer it to a
working model for the dental technician.
191 Dental implant/prosthesis handling This is a hand-held manual dental instrument
forceps designed for grasping and holding a dental
devices(e.g., crown, bridge, screw) during its
application to a patient's oral cavity
192 Dental impression adhesive A liquid material specifically made to give adhesion
of an impression material to the impression tray.
193 Dental impression material Intended to take an oral impression.
194 Dental impression material kit, A collection of non-sterile devices designed to obtain
reusable a negative imprint of the teeth. The kit typically
includes dental impression materials and a dental
impression tray(s).
195 Dental impression material kit, A collection of non-sterile devices designed to obtain
single-use a negative imprint of the teeth. The kit typically
includes dental impression materials and a dental
impression tray(s).
196 Dental impression material mixer An electric device used to mix impression materials
immediately before use at the chair side
197 Dental impression tray material A material intended to be used to create a custom
impression tray intended for filling with dental
impression materials; it is not intended for the
fabrication of a patient-worn dental appliance.
198 Dental impression tray, A impression tray is a metal or plastic device
reusable intended to hold impression material, to make an
impression of a patient's teeth to reproduce the
structure of a patient's teeth.S.No. Device Name Intended Use
199 Dental impression tray, A impression tray is a metal or plastic device
single-use intended to hold impression material, to make an
impression of a patient's teeth to reproduce the
structure of a patient's teeth.
200 Dental laboratory CAD/CAM unit This is a laboratory based device that is intended to
be used to aid in the computer-aided design (CAD)
and manufacturing/production (CAM) of dental
restorations in the dental laboratory.
201 Dental material application tool, Intended to be used in dentistry for the application of
reusable a dental material (e.g., composite resin, etchants,
etc.) to a dental prosthesis or to a patient’s
tooth/teeth or elsewhere in the oral cavity
202 Dental material heater Intended to heat regular (paste) and flowable
composite material, including bulk fill composites,
compules, porcelain veneers and onlays
203 Dental material mixing surface, Intended to be used as a surface to mix dental
reusable materials.
204 Dental material mixing surface, Intended to be used as a surface to knead or mix
single-use dental material (impression material, cement, etc).
205 Dental matrix wedge Used to wedge between teeth to create space when
applying restorative materials
206 Dental pick Intended for the removal of plaque and/or debris
from the proximal surfaces of teeth and the gingival
surfaces of fixed prostheses.
207 Dental precision attachment This is a hand held dental laboratory instrument that
fitting/adjustment tool is intended to be used in a dental laboratory or
dental surgery during fabrication or revision of a final
dental prosthesis (e.g., denture, crown, bridge) to
integrate and/or adjust the fitting between male and
female precision attachments.
208 Dental resin applicator Intended to be used for the application of a dental
restorative material (e.g., amalgam, resin) to a
patient’s tooth/teeth; the restorative material is not
included.
209 Dental rubber dam Dental rubber dam is a stretchable sheet used to
isolate a field of work from the rest of the oral cavity
in dentistry.
210 Dental spatula, reusable Used for kneading or mixing dental material
(impression material, cement, etc).
211 Dental spatula, single- use Used for kneading or mixing dental material
(impression material, cement, etc).S.No. Device Name Intended Use
212 Dental suction system fluid- A separator used in the oral cavity for the separation
separation unit of fluids (saliva, blood) from gases to avoid liquids
from entering the suction pump (i.e., dry
suction).
213 Dental surgical microscope This is a dental device that is intended to be used
to magnify and visualize minute intraoral structures
during dental examination and dental surgical
procedures in the mouth.
214 Dental torque wrench adaptor It is used to enable connection of the main body of
the wrench to a specific endpiece(s).
215 Dental X-ray beam aligner Intended to assist the dental radiographer position
the positioning indicator device relative to the tooth
and receptor
216 Dental X-ray film holder It is used to hold the dental xray films and position it
to the right angle inside the mouth to aim taking an
accurate xray
217 Dental/oral lavage unit (water Intended to inject a stream of water on teeth to
flosser) remove dental plaque in between teeth and improve
gum health. It is intended as an OTC (home use)
device.
218 Dental-professional prophylaxis A rotary dental instrument with natural or synthetic
brush/Dental polishing brush bristle brushes intended to be used by a dental
hygienist and/or dentist to clean and polish teeth.
219 Dentifrice Prophylaxis pastes without fluoride intended to be
used by professionals for tooth cleaning and
polishing procedure by abrasion/mechanical
cleaning only.
220 Dentures cup This cup is intended to hold patient dentures when
they are not in the mouth.
221 Dermatome skin approximation tape Intended for attachment onto a skin graft knife to
collect a skin graft tissue.
222 Dermatoscope Intended for non-invasive, visual inspection of intact
skin by a healthcare professional.
223 Derotation bar with Traction Intended for lower limb traction and aid in early
healing, correction of drop foot
224 Diagnostic condensing lens Intended for use in binocular indirect
ophthalmoscopy to focus reflected light from the
fundus of the eye.
225 Diagnostic X-ray system positioning Diagnostic X-Ray System positioning frame
frame
226 Diagnostic x-ray tube mount Intended to support and to position the diagnostic x-
ray tube housing assembly for a medical
radiographic procedure.S.No. Device Name Intended Use
227 Dialysis bag clamp/clip Intended to be used for opening or closing the
dialysis tube.
228 Dialysis set holder To hold and secure in position a dedicated set being
used during a dialysis procedure.
229 Diaphragm wearable urinal A non-sterile urine drainage device designed for
men with incontinence consisting of a front piece
with a scrotal support and a leak-proof, flexible
diaphragm through which the penis passes into a
closed coneshaped tube connected to a leg bag into
which the urine is collected.
230 Digital examination camera Digital camera for close-up skin inspections or
general examinations.
231 Direct ophthalmoscope eye cup The device is intended to be attached to the distal
(patient-contact) end of a direct ophthalmoscope
head to facilitate appropriate positioning around the
patient’s eye socket during an examination.
232 Disability vehicle, moped A moped that provides mobility to a disabled person
233 Disposable Kelly pad Intended to funnel blood to a collection device in
order to help detect postpartum hemorrhage
234 Dissection board A device on which an object is placed for support
during dissection procedures
235 Douche kit A packaged collection of items (douche solution
prefilled in a douche unit) used to provide cleansing
of the vaginal area of the user's body.
236 Drainage tube A hollow device used as a conduit to remove fluids
or purulent material from a cavity, wound, or infected
area.
237 Drape adhesive Intended to be placed on the skin to attach a
surgical drape.
238 Draping incontinence liner A non-sterile padded sheet intended to cover a
device/piece of furniture (e.g., wheelchair, bed, sofa)
occupied by an incontinent person to catch and
retain urine.
239 Dressing retention garments Intended for use in wet and/or dry wrapping and
dressing retention in the treatment of atopic eczema.
240 Drip wearable urinal A non-sterile urine drainage device designed for
men to contain a moderate leakage consisting of a
front piece with an integrated tubular sheath that fits
fully over the penis and into which dribbling urine is
collected.
241 Dry powder inhaler Intended to administer powdered medicine through
the mouth and into the bronchial airways.S.No. Device Name Intended Use
242 Dry salt therapy device Intended to provide an inhalation of prefilled salt
particles through the mouth and into the bronchial
airways to induce natural self-cleansing
mechanisms that flush away the impurities from the
surface of cells and mechanically clean the airways.
243 Drying chamber for breathing circuits A chamber designed for drying breathing circuit
equipment.
244 Ear bowl Intended to fit the curvature of the head and sit
closely under the ear lobe to enable ear treatments.
245 Ear canal impression tray Intended to hold and confine the impression material
in opposition to the surfaces to be recorded, and to
control the impression material while it sets to form
the impression of the ear canal.
246 Ear canal light Intended to illuminate the ear canal.
247 Ear Irrigation kit Irrigates the ear canal with solution to clear wax and
debris.
248 Ear microsystem needle Intended to apply continuous pressure to stimulate
meridian points during auriculotherapy
249 Ear wick Intended to minimize bleeding during ear surgery.
250 Elastic adhesive Bandage It is intended to secure dressings and for strapping
on intact skin
251 Elasticated cohesive Bandage It is intended to secure dressings and for strapping
on intact skin
252 Elbow immobilizer A non-rigid external device, usually made of a fabric,
used to temporarily render the elbow immovable to
support healing of an injury or a surgical wound.
253 Elbow orthosis A prefabricated (non-customized) externally applied
and wearable orthopaedic appliance designed to
encompass the elbow joint to support, align, prevent,
or correct deformities/injuries or to improve function
of the elbow.
254 Electric dental chair without A mains electricity (AC-powered) device designed to
operative unit support a patient in a seated position to facilitate
dental examination, treatment, and/or minor surgery
procedures. It does not include operative unit.
255 Electric stander Standing frames for those with standing difficulties
256 Electric toothbrush Intended to remove plaque, tartar, food debris, etc.
from teeth and gums and aid in prevention of dental
caries, etc.S.No. Device Name Intended Use
257 Electrical-only medical device This device connects incompatible plugs/sockets on
connection adaptor related medical devices (e.g., video control centers,
peripheral devices and controller) and/or cables and
relates the control signals.
258 Electronic occlusion spectacles Intended to test and train vision for conditions where
decreased visual acuity may be due to unequal
vision in the eyes.
259 Electrosurgical electrode holder A device intended to be used to house active hand-
controlled electrosurgical electrodes (pencil
electrodes) when not in use during the surgical
procedure.
260 Emesis bag A disposable device intended to collect and contain
a patient's vomit and eliminate exposure to vomit
until it is convenient to dispose of the bag and its
contents.
261 Endaural wax extraction curette This device is intended to simply extract ear wax
using a soft silicone tip that expands in ear cavity to
aid extraction.
262 Endoscope calibration cover, A plastic cap/cover designed to be placed onto the
reusable distal end of an endoscope to allow white balance
and/or 3-D adjustment to be calibrated in the
electronic control unit of the endoscope. This is a
reusable device.
263 Endoscope channel cleaning valve An adapter or valve to be fitted to an endoscope for
cleaning purposes
264 Endoscope cleaning brush A device used to remove dirt or debris from the
working channel (s) and irregular surface of the
endoscope prior to disinfection and sterilization.
265 Endoscope collector A device intended to collect the excreted endoscopic
video capsule camera.
266 Endoscope flushing adaptor, single- An adapter intended to be fitted to an endoscope
use air/water channel for flushing of the endoscope
during post-procedural ‘precleaning’ step of
endoscope reprocessing after endoscopic
procedure.
267 Endoscope leak tester tubing Leak tester tubing for use during endoscope leak
test.
268 Endoscope/instrument holder, A manually adjusted device intended to be used to
manual-adjusted hold, maintain in a desired position, and enable
positional adjustment of an endoscope (e.g.,
laparoscope) and/or associated instruments/devices
during an endoscopic examination/surgical
procedure.
269 Endoscopic irrigation/aspiration foot- A manual, foot-operated device intended to be used
pedal in conjunction with an irrigation tubing set to facilitate
delivery of sterile irrigation fluid.S.No. Device Name Intended Use
270 Endoscopic video image interpretive The device is intended to be used by trained
unit clinicians as an adjunct to video Endoscopy for the
purpose to highlighting regions with visual
characteristics consistent with different types of
mucosal abnormalities.
271 Endoscopic video image processor A unit designed to receive the electronic signals sent
from a video endoscope and may/may not
compensate for/enhance the colour and light
qualities provided.
272 Endotracheal tube holder Intended to provide a reliable stabilization of
endotracheal tube after intubation
273 Endotracheal tube introducer Intended to help with the insertion of an
endotracheal (ET) tube into the airways of a patient
during intubation
274 Enema bag Intended to be used to hold an enema solution for
administration into the rectum
275 ENT chair, electric Intended to support a patient in a seated position,
electrically control position in a way to facilitate ear,
nose, throat examination, treatment, and/or minor
surgery.
276 ENT chair, mechanical Intended to support a patient in a seated position,
mechanically control position in a way to facilitate
ear, nose, throat examination, treatment, and/or
minor surgery.
277 ENT surgical microscope Intended to magnify minute structures (e.g., nerves,
vessels) in the performance of ear, nose, and/or
throat (ENT) surgery requiring high magnification
and adjustable focusing.
278 ENT transilluminator Intended to illuminate sinus tissue during an
ear/nose/throat (ENT) procedure to render the tissue
translucent for examination
279 Enteric stomal shield A non-sterile cap intended to be placed over an
enteric stoma to protect it from harmful external
influences (e.g., knocks, friction).
280 Enuresis alarm The device that activates a signal when a small
quantity of urine is detected by a sensing
mechanism to help a child with training the bladder.
281 Epileptic seizure alarm Intended to alert or notify healthcare professional or
next of kin when an epileptic patient (often pediatric)
gets a seizure attack.
282 Euthyscope Intended to project a bright light encompassing an
arc of approximately 30 degrees on the fundus of
the eye for the treatment of amblyopia.S.No. Device Name Intended Use
283 Exothermic heat therapy pack Intended to be applied to the body surface,
sometimes with pressure, to provide heat therapy to
reduce muscle spasms and cramps and/or for joint
and muscle stiffness and pain.
284 External asembled lower limb Intended for use as an preassembled external
prosthesis artificial limb for the lower extremity.
285 External limb prosthesis socket liner Intended for use as an interface that goes between a
person's skin and his or her prosthetic to protect the
wearer's skin while enhancing comfort and
maintaining a more consistent fit.
286 External lower-limb prosthesis A component of an external lower limb prosthesis
socket designed to fit over a residual limb after amputation
at any hip, knee, or ankle-foot level, and intended to
function as the limb-prosthesis interface and to
provide support, stabilization and suspension.
287 External nasal splint Intended for external use for immobilization of parts
of the nose.
288 External silicone breast prosthesis Intended to restore normal contour and improve
function for patients who have experienced partial or
total loss of their breast to traumatic injury, disease
or due to surgical removal of the nose (rhinectomy).
289 Extractor Used to aid in the removal of foreign objects from
superficial skin tissue.
290 Eye cup Intended to fit around the eye socket and placed
over the eye to allow washing of the affected eye.
291 Eye irrigation shield Intended for use with an eye irrigation kit/system to
direct irrigation solution to the surface of the eye and
allow the solution to gently lavage the surface of the
eye.
292 Eye pad, non sterile Intended for use as a bandage over the eye for
protection or absorption of secretions.
293 Eye patch, non-sterile A device with a synthetic origin used to close/cover
one or both eyes, for the purpose of protecting the
eye after a procedure or as part of an ophthalmic
therapeutic intervention.
294 Eye patch, non-sterile Intended to provide temporary occlusion for the eye
in the treatment of Amblyopia, diplopia or as a
occluder for vision or field testing.
295 Eye spud Intended to remove a foreign body/object embedded
in or adhering to the surface of the eye globe.S.No. Device Name Intended Use
296 Eyelid clamp Intended to automatically grasp and hold the eyelid
during an ophthalmic surgical intervention.
297 Eyelid weight, external Intended to be applied to the outside of the upper
eyelid to "lidload" the eyelid to restore upper eyelid
muscle function.
298 Face shield Intended to protect the wearer's entire face (or part
of it) from hazards such as chemical splashes (in
laboratories or in industry), or potentially infectious
materials (in medical and laboratory environments).
299 Feeding nipple Intended for use as a feeding nipple for infants with
oral or facial abnormalities
300 Felt tangent screen Intended for assessing the extent of the patient's
peripheral visual field by mapping the visual
response to a test object moved from the periphery
towards the centre of the screen.
301 Female wearable urinal, reusable A non-sterile, urine drainage device designed for
women that typically consists of a flexible tube
attached to a collector that is specially formed to
securely fit around the female genitals to provide a
route to channel urine, via a tube, into a collection
bag.
302 Fiber cast bandage Intended to be used as a medical dressing made of
synthetic materials to support and protect bones that
have been broken or joints that need stabilization.
303 Filter for dental suction equipment Filter that ensures debris does not enter dental
suction equipment
304 Filter for gas central supply system Designed to remove particulates and volatile organic
compounds (VOCs) from the gas flowing into
incubators used in IVF procedures.
305 Finger and toe bandage An elastic, tubular device intended to be worn
over/around the limb
(arm/leg) and/or finger of a patient affected by a skin
condition/disorder (e.g., eczema, wound, fragile
skin) to protect the skin typically after treatment with
a medication (e.g., ointment, cream), and/or to
support a dressing over a wound/injury.
306 Finger Cot/brace Intended to support, align, prevent or correct
deformities/injuries or to improve function of fingerS.No. Device Name Intended Use
307 Finger/hand exerciser Intended primarily to strengthen the muscles of the
fingers and hands through repetitive finger/hand
motion against resistance from elasticity or density
(post fracture/stress/weak forearm and grip
strength).
308 Finger/thumb prosthesis Intended as an artificial substitute for a missing
finger or thumb
309 Flatus tube, single-use A soft and pliable tube intended to be inserted
through the anus to relieve colic in infants. It is a
single-use device.
310 Flex bar Intended to increase tendon strength and reduce
elbow pain for those who suffer from tennis and
golfer's elbow.
311 Flotation therapy bed, adult A mains electricity (AC-powered) bed designed to
minimize pressure points on a patient's body by
providing contact with as much of the body surface
as possible, typically through a mattress that
contains a large volume of constantly moving media,
e.g., water, air, or mud that lifts the patient to
simulate a floating effect. It is used in cases of
decubitus ulcers or where a patient has little
remaining body fat and the displacement of body
weight is vital for treatment and/or comfort.
312 Flotation therapy bed, neonatal A fixed (non-adjustable) device designed with a
mattress or cushions containing air, water, gel, or
other appropriate material used for the continuous
care of newborns, and sick and/or premature babies.
313 Fluid delivery mount, general- The device is designed to hold the fluid bags when
purpose gravity irrigation is needed for scope surgery.
314 Foot traction kit It is used in relieving pain due to muscle spasm,
maintaining the limb in a position of comfort and to
restore and maintain the alignment of bone due to
fracture or dislocation.
315 Footstool, conductive A low stool for standing on to compensate for height
differences. It is intended to be used in, e.g.
examination rooms or operating theatres.
316 Forceps, dressing A surgical instrument with scissor like handles used
to grasp dressings, e.g. cotton swabs, towel, lints
317 Forceps, sterilizer transfer Forceps with specially designed blades used to
handle sterile instruments or implants.S.No. Device Name Intended Use
318 Fornixscope Intended to provide indirect access and viewing of
the upper conjunctival fornix and inner surface of the
eyelid as an alternative to eyelid eversion.
319 Fresnel lens Intended to be applied to the back of spectacle
lenses to focus light to a focal point to help manage
various vision conditions.
320 Fresnel prism Intended to be applied to spectacle lenses to give a
prismatic effect typically to manage strabismus or
other eye muscle dysfunction.
321 Fundus camera It is intended to capture and document digital
images of the posterior and anterior segments of the
human eye.
322 Fundus camera, pediatric Intended to capture digital color images of the retina
of infants having less than 55 weeks of Post
Menstrual Age (PMA), while there eyes are dilated
using mydriatic drops under clinical control.
323 Gait rehabilitation electronic walker A mobility and transfer device that helps a health
care professional raise a patient to a standing
position, providing support for standing or
ambulation, or lifting a patient in the seated posture
and transferring them between wheelchairs, chairs,
toilets, beds or therapy tables.
324 Gait Trainer It is used to assist and train a person with physical
disabilities to relearn/improve walking.
325 Gait trainers-Unweighing System Intended for partial weight-bearing therapy in
rehabilitation
326 Gas sampling line filter, reusable The device is indicated for adult, pediatric,
infant/neonatal patients for removal of moisture from
the gas sample.
327 Gastric pH strip pH strips to indicate the pH level of human gastric
aspirate
328 Gel base for metallic neuro head It is used for providing support patient's head in a
frame suitable and stable position (e.g., supine, lateral, or
prone) during intracranial and spinal surgeries.
329 Gel knee ring Intended to be worn around the knee for pain relief
and immobilizationS.No. Device Name Intended Use
330 Gel-filled bed mattress A large, durable, fabric case filled with various
densities of foam that support a gel structure,
designed to be placed on a bed mattress support
platform to provide a comfortable surface on which
an occupant can lie, rest, and sleep, and intended to
distribute body weight over a large surface area
typically to help relieve pressure points for comfort
and improve blood circulation to prevent pressure
sores.
331 Gel-filled bed mattress overlay A gel-filled pad or thin mattress, usually full-body
length, which is placed on top of a bed mattress to
distribute an occupant's body weight over a large
surface area, typically to relieve pressure points for
comfort and to prevent pressure sores.
332 Gel-filled chair cushion A gel-filled pad designed to be placed on the seat of
a chair to distribute an occupant's body weight over
the surface of the buttocks, typically to relieve
pressure points for comfort and to prevent pressure
sores.
333 General-gas low pressure tubing, Intended to enable nitrogen or instrument air to be
reusable delivered to the console from the wall in the hospital.
334 General-purpose diagnostic x-ray A device that consists of preserved human or animal
phantom, anthropomorphic tissue, or a two or three-dimensional (3-D) tissue-
equivalent model designed to mimic the functional,
physical, or a combination of these characteristics of
a normal or diseased human organ or organ
systems. It is a quality assurance (QA) device
intended to permit both subjective and quantitative
evaluation of the overall function of both
conventional and digital general-purpose x-ray
systems and associated image acquisition, display
and analysis computer programs.
335 General-purpose diagnostic X-ray Intended to provide for routine and periodic
phantom, test object verification of the energy, hardness and intensity of
an X-ray beam
336 General-purpose manually-operated A mobile, manually-operated hydraulic table
operation table designed to be adjusted to support a patient during
many types of surgical interventions.
337 General-purpose Intended for use in general diagnosis and
diagnosis/treatment table procedures in examination room to aid patient
examination.
338 Gingival barrier (non-medicated) Intended for protection of gingival area during tooth
bleaching processS.No. Device Name Intended Use
339 Gonadal radiation protector Intended to attenuate unnecessary radiation
exposure in diagnostic, medical or dental
procedures, and shield the gonad of the patient and
the operator.
340 Gonio lens Intended for viewing the anterior chamber angle and
retina
341 Gravity enema set Intended to deliver an injection of fluid (e.g., saline
solution) into the rectum to facilitate evacuation of
the large intestine.
342 Grip-enhancing exoskeleton Intended to improve grip strength and hand function
for people (from children to elderly people) with
impaired hand function. The condition may be (but is
not limited to) due to orthopaedic or neurological
problems, from birth or acquired. The device mimics
the user’s grip movements and supports the users’
natural grip.
343 Gynaecological bib Intended to be worn by the patient during
gynecological examinations and procedures.
344 Gynaecological operating table top Intended to support a patient during gynaecological
surgical procedures
345 Gynaecological operating table, Intended to support a patient during gynaecological
electrohydraulic or surgical procedures
electromechanical or hydraulic
346 Gynaecological surgical microscope Intended to improve visualization of anatomical
structures via
transmitted light during gynaecological surgery
(e.g., on the fallopian tubes).
347 Gynaecological Intended to support a woman's body in the
examination/treatment table appropriate positions during gynaecological
examinations.
348 Haidinger brush imager Intended to produce an image which facilitates
visual function evaluation, particularly the macular
integrity.
349 Hallux valgus metatarsophalangeal A prefabricated (non-customized) non-rigid, home-
orthosis use device intended to be worn on the foot to help
prevent and/or reduce hallux valgus deformity,
thereby reducing walking pain and bunion formation.
350 Hand exerciser table This modality exercise is meant for rehabilitation of
the hands, fingers, and wrist disorders injuries &
fractures.
351 Hand/finger splint Intended to immobilize an injured hand to protect
from injuries to the digits, metacarpals, and wrist
during the healing process.S.No. Device Name Intended Use
352 Hand-carried stretcher Intended to carry patient as an assistance for injury
or disability.
353 Handgrip cover for laryngoscope Intended to be placed over the reusable
laryngoscope device during intubation to create a
barrier in order to reduce the cleaning time and
turnaround time of the laryngoscope blade for reuse.
354 Handgrip cover for surgical light Intended to provide physical barrier on a handgrip to
prevent cross-contamination between the operating
room surgical lights (non-sterile) and the operating
room personnel.
355 Handgrip cover for vein illumination The cover is intended to isolate vein illumination
device devices and simplify cleaning after use.
356 Hand-held telescope Intended to enlarge images for a visually impaired
patient/person.
357 Hand-held urinal, female Intended as a container/set to be directly urinated
into by a female (typically bed-bound) patient for
excretory purposes.
358 Hand-held urinal, male, reusable Intended as a container to be directly urinated into
by a male (typically bed-bound) patient for excretory
purposes.
359 Head marking cap A head covering designed as a cap intended to be
worn on the head of a patient to allow a healthcare
professional to mark specific reference points on the
head during a procedure [e.g., transcranial magnetic
stimulation (TMS)] as an alternative to marking the
scalp directly or to avoid cutting the patient’s hair.
360 Head reflector A head-worn device consisting of a circular concave
mirror (reflector) attached to a headband designed
to reflect light to a site of examination/minor
intervention (e.g., the nose, throat, or body surface)
on a patient.
361 Head Rest/Ring Intended to position and protect a patient's head,
face and neck during prolonged surgeries
362 Heal cushion/Spur pad/cup Intended to worn on the heel to relieve heel pain,
plantar fasciitis, foot pain, pain during walking,
calcaneal spur, sprain and strain of the foot, ankle,
feet and knee pain.
363 Heat-sealing device Intended for medical purposes that uses heat to seal
plastic bags containing blood or blood components.S.No. Device Name Intended Use
364 Heel stirrup Intended to position and support the patient’s foot,
lower leg and upper leg in a variety of surgical
procedures including, but not limited to gynecology,
urology, laparoscopy, general and robotic surgery.
365 Hip pad positioning device It is used to support the patient hip during prolonged
surgeries.
366 Hip protector (Belt) Intended to be worn by older adults or patients who
have balance/vision problems, bone conditions, or at
risk of falling to prevent hip injuries and fractures.
367 Hip shield A mechanical guard worn over the hip to reduce risk
of injury in the case of a fall
368 Horizontal non-powered traction Intended to be attached to a table for the application
system of constant horizontal traction forces to the cervical
or lumbar vertebrae of patient by means of attached
harnesses.
369 Hospital Backrest Intended to support patients with spinal problems
and pain management
370 Hruby fundus lens Intended for use in the examination of the vitreous
body and the fundus of the eye under slit lamp
illumination and magnification.
371 Hydraulic/pneumatic external knee This device is intended for transfemoral amputees,
prosthesis is a prosthetic device designed to restore some
function of an anatomical knee joint.
372 Hydrocollator pack Intended to be applied to the body surface to provide
heat therapy to reduce muscle spasms and cramps
and/or for joint/muscle stiffness and pain
373 Hydrotherapy equipment/tank Used for rehab treatment requiring resistance
created by water to aid in injury recovery, improve
blood circulation, and decrease inflammation,
speeding recovery time
374 Hydrotherapy treadmill Intended for use in partially immersed in water, e.g.,
in a hydrotherapy tank, to provide additional
resistance to the treadmill walking exercise without
increasing the impact and/or stress on the patient's
joints.
375 Hypothermia-prevention cap Intended to prevent heat loss from the patient’s head
during surgery and under anesthesia.
376 Ice bag Intended to alleviate pain and/or promote healing in
minor injuries of the body or for application around
the neck or limbs.S.No. Device Name Intended Use
377 Image display monitor mount A dedicated mount onto which a visual display unit
(VDU), e.g., a patient monitor, can be placed and
secured so that it is safely mounted in a position
suitable for viewing. manufactured for hospital use.
378 Incentive spirometer Intended to be used in respiratory therapy to
encourage and motivate deep-breathing
manoeuvres, typically for the postsurgical treatment
and prevention of atelectasis (lung collapse) and to
help facilitate airway opening and clearing.
379 Incontinence device suspender A device used by a person with a disability to secure
a body-worn incontinence device [e.g., a nappy
(diaper) or a pad] in a stable and safe position
380 Incontinence penis clamp, reusable Intended to gently compress the penis, either the
proximal shaft or the glans penis, to occlude the
urethra and prevent involuntary urination/dribbling
for men who are incontinent of the bladder.
381 Indirect binocular ophthalmoscope An ophthalmic instrument designed to examine the
interior of the eye allowing the examiner to clearly
see a wide angle, stereoscopic impression of the
details of the fundus (retina) and other structures.
382 Infant acoustic earmuffs A device consisting of two ear-covering cups (one
for each ear) intended to provide noise insulation for
neonates/infants in a special care unit.
383 Infant cap To be used with an infant nasal CPAP respiratory
support breathing system to act as a stabilizing head
strap.
384 Infant care table Intended for use in nursing, e.g., washing or
changing of nappies, of newborn babies.
385 Infant incubator warming hood Intended to provide warmth to an incubator chamber
by placement above the chamber.
386 Infant inguinal hernia truss Intended to be worn over the groin to prevent
protrusion of abdominal contents in an infant with an
inguinal hernia.
387 Infant limb immobilizer, reusable Intended to temporarily render parts of an infant's
body immovable, e.g., the arms and/or feet while the
patient undergoes therapeutic or diagnostic
interventions.
388 Infant limb immobilizer, single- use Intended to temporarily render parts of an infant's
body immovable, e.g., the arms and/or feet while the
patient undergoes therapeutic or diagnostic
interventions.S.No. Device Name Intended Use
389 Infant oral pacifier To be used to calm the premature infant for longer
duration specifically during Nasal CPAP or when
infant is intubated and on mechanical ventilation. For
hospital use only.
390 Infant resuscitation table It is a patient platform that can be used to facilitate
neonatal transition at birth. It provides a stable
platform for mother side resuscitation and
stabilization practices.
391 Infant sleep positioner Intended to modify the sleeping position/posture of
infants to prevent deformational plagiocephaly, a
flattening of the back of the skull from a consistent
back-sleeping position.
392 Infant-hammock bed mattress Intended to be placed in a
cot/crib/bassinet/bed/incubator and to cradle a
young infant during sleep/rest, and can used for
phototherapy, transportation and burns patients.
Intended to help reduce the risk of infant
injuries/disorders such as suffocation, flat head
(plagiocephaly), sudden infant death syndrome
(SIDS), pressure sores, and hyperthermia.
393 Infant-hammock bed mattress Intended to be placed on a cot/crib/bed mattress and
overlay to cradle a young infant during sleep/rest to help
reduce the risk of infant injuries/disorders such as
suffocation, flat head (plagiocephaly), sudden infant
death syndrome (SIDS), and hyperthermia.
394 Inflatable hot/cold therapy A non sterile assembly of devices that are intended
pack/manual pump to be applied with pressure to a body surface to
provide cold or heat therapy to that surface and/or
underlying tissue, e.g. the muscle. This device
typically consists of a cold/heat therapy pack, air
inflation sleeve and a manual air pump with
connection tubing. It is reusable and intended in
both the professional and home setting.
395 Inflatable limb splint A sleeve placed around an arm or leg and inflated to
immobilize the limb.
396 Inflatable patient transfer sliding An inflatable device designed to support a
mattress, single-use recumbent patient on a bed or table and assist in the
physical movement of a patient for safer, easier
transfer and positioning in Trendelenburg and
Reverse Trendelenburg.
397 Infusion line clamp A device intended for the clamping of medical tubes.S.No. Device Name Intended Use
398 Infusion line securement clip, single- The device is intended to hold tubing to avoid
use kinking of the tube during infusion and patient
moving.
399 Inguinal hernia belt (Adult)/surgical A reusable device Intended to relieve discomfort and
truss, reusable hernia pain caused by an inguinal or sports hernia
400 Inguinal hernia belt (Adult)/surgical A single use device intended to relieve discomfort
truss, singe use and hernia pain caused by an inguinal or sports
hernia
401 Injection site desensitizer, tactile A non-sterile, noninvasive reusable device intended
to be used to manually apply tactile pressure stimuli
to a skin-surface injection site, prior to/during
injection, to reduce the pain/anxiety/stress
associated with injecting.
402 In-line arterial blood sampling set A collection of devices designed to obtain an in-line
arterial blood specimen while maintaining a closed
system.
403 In-line backflow valve A general-purpose device used in medical tubing or
pipelines to prevent the backflow of gases or liquids.
404 Instrument lubricant Intended to be applied to a surgical instrument prior
to sterilization for purposes of
lubrication/maintenance (e.g., to prevent moving or
mating parts from sticking together during use,
inhibit corrosion, and to improve longevity of the
instrument)
405 Integration Unit for Flat panel x-ray A portable, electrically-powered device intended to
detector enable a direct flat panel detector (not included) to
be integrated as part of an analogue x-ray [i.e.,
screen-film, computerized radiography (plate)]
system to convert the analogue x-ray system into a
digital x-ray system (retrofit) using the same
modality components.
406 Intestinal ostomy base plate The base plate is intended to fix the ostomy bag and
adhere to intact skin around the stoma.
407 Intestinal stoma shield/support belt, A non-sterile plate intended to be placed over an
reusable enteric stoma to protect it from harmful external
influences (e.g., knocks, friction), to reduce the risk
of stomal herniation, or to help maintain adhesion of
the base plate to the skin.
408 Intraoperative chest positioner A preformed reusable pad designed to be attached
to an operating table for stabilizing a patient's chest
to adequately position, support, and reduce pressure
on the bony prominences of the body part during
intraoperative proceduresS.No. Device Name Intended Use
409 Intravenous access monitoring An alarm system that connects to a sensors
system, line-disconnection around/on a venous puncture site dressing or
catheter connection to detect blood or disconnection
of the catheter.
410 Intravenous catheter holder, non- It is a skin adhesive device for the securement of
sterile urinary catheters and medical tubing as part of
ongoing catheter care.
411 Intravenous hanger, wall-mounted The device is intended to be used within the medical
application to hold infusion bags within the approved
load range.
412 Intubation teeth protector A device designed to fit over the upper and lower
sets of teeth to protect them from damage during
endotracheal (ET) tube intubation procedures.
413 Inversion table Intended to support the body of a patient and
provide traction for the back muscles and spine by
allowing the patient manually invert their entire body
in a supine position (feet up and head down),
thereby assist in alleviating back pain.
414 Irrigation kit To irrigate the nasal passages of infants and young
children.
415 Irrigation tip, surgical mist A device that is designed to connect to an air/water
syringe to blow a mixture of air and/or water into a
patient's mouth during dental procedures.
416 Jaw exerciser Hard gum is used to exercise jaw muscles for
temporomandibular disorders, increased saliva
production, helping to improve efficient food chewing
and swallowing.
417 Kinesiology tape used to support and relieve pain in muscles, joints,
and/or ligaments. It reduces swelling, increases
mobility and enhances recovery.
418 Kinetic bed Intended to enable continuous change of the
patient's lying position.
419 Knee cap/brace/wrap Intended to limit the mobility of the knee to relieve
pain in conditions of arthritic pain, ligament/muscle
injury, surgical procedures, fractures, sprains, etc.
420 Knee ice wrap Intended to relieve pain, swelling and inflammation
in the knee due to ACL, arthritis, sports injuries,
sprains, strains, muscle fatigue and surgery.
421 Knife handle A device that is an interchangeable component of a
scalpel and that functions as a handle designed to
mount a compatible blade.S.No. Device Name Intended Use
422 Knife sharpener A device used to create or re-establish a thin, keen
edge or fine point on an instrument used to cut, such
as a knife
423 Laparoscope laser adaptor Intended to connect the laparoscope to the laser or
the laser arm for laparoscopic laser treatment.
424 Laparoscopic surgery handle A manually operated handle of various
configurations to hold instruments used in
laparoscopic surgery.
425 Laparoscopic tray Intended for holding laparoscopy instruments during
a laparoscopic intervention or sterilization.
426 Laryngeal airway introducer A device intended to aid insertion of a laryngeal
airway into the pharyngeal cavity of a patient while
reducing or eliminating the need for finger
manipulation within the mouth.
427 Laser protection eyewear Intended to be used by the staff in an operating or
treatment room where a laser is being used, in order
to protect their eyes from injury during the laser
surgery.
428 LED transilluminator Intended to provide optimal LED light in the
incubator
429 Leg intraoperative repositioning A mechanical device intended to be used to help
support support the weight of a patient's leg when the leg
needs to be repositioned during an orthopaedic
procedure. It is designed to be attached to the
operating table.
430 Lens system, high magnification A device (lens) used to observe the retina or anterior
chanber of the eye.
431 Lice comb Removes head lice eggs and nits and can be used
in conjunction with all lice treatments
432 Light beam patient position indicator Intended to project a beam of light (incoherent
light or laser) to determine the alignment of the
patient with a radiation beam.
433 Limb/torso/head restraint, reusable The devices are designed to position and support
patients in a variety of surgical procedures including,
but not limited to gynecology, urology, laparoscopy,
general and robotic surgery during Reverse
Trendelenburg positioning.
434 Liquid barrier dressing, dental Protection of gingival area during tooth bleaching
process
435 Liquid crystal vein locator Intended to indicate the location of a vein by
revealing variations in the surface temperature of the
skin.S.No. Device Name Intended Use
436 Lower limb exerciser Intended to provide above and below knee
amputees the ability to improve muscle and
strengthen residual limbs
437 Lower limb sliding exerciser, non- A non-powered device intended to encourage active
powered movement of a patient’s lower limb(s) by assisting
flexion/extension at the knee for rehabilitation. This
is a reusable device.
438 Lower-limb orthosis The device is an externally-applied wearable
appliance intended to support and correct
deformities of the leg and/or feet. It may be one of
numerous different designs and is typically made of
synthetic and textile materials. This is a single-
patient reusable device.
439 Lower-limb warming sock/stocking, Intended to prevent heat loss during surgery and
single-use under anaesthesia. The patient’s lower extremity is
placed in the legwarmer which is equipped the same
way as socks.
440 Maddox trial lens Intended as a device that change the size, shape,
and colour of an image to dissociate the eyes in the
evaluation of eye muscle dysfunction.
441 Magnetic field shielding material for An accessory intended to be used on Cochlear
cochlear implants implant recipients to prevent implant magnet
dislodgement during MRI scans. The device is
placed externally on the recipient's head by a
healthcare professional prior to undergoing an MRI
procedure.
442 Mammographic x-ray phantom, test A device that consists of a uniform density or a two
object or three-dimensional (3-D) pattern of objects,
materials or openings of varying dimensions. It is a
quality assurance (QA) device used in both
subjective and quantitative evaluations of various
calibration and performance characteristics of
dedicated digital or conventional diagnostic x-ray
mammography systems or general-purpose x-ray
systems adaptable for mammography applications.
443 Mammographic x-ray system A mechanically, electronically or software-controlled
compression paddle component of a mammographic x-ray system used
to flatten and stabilize the breast during
mammography studies or mammography system-
guided biopsy procedures.S.No. Device Name Intended Use
444 Mandible-repositioning sleep- A removable intraoral device designed to alleviate
disordered breathing orthosis sleep-disordered breathing conditions (e.g., snoring,
obstructive sleep apnoea) by repositioning and/or
controlling the lower jaw (mandible), typically in a
downward and forward position.
445 Manual adjustable hospital bed Intended for medical purposes that consists of a bed
with a manual mechanism operated by an attendant
to adjust the height and surface contour of the bed.
446 Manual dental burnisher, reusable Used to polish the surface and smooth the margins
of restorations during dental procedures.
447 Manual dexterity assessment The software is intended to detect micrographia
software (smallness of writing), bradykinesia (slowness of
movement) and tremor with the
help of an off-the-shelf tablet and a digital pen. This
is not intended for self-assessment.
448 Manual dexterity test Dexterity devices intended to evaluate motor
coordination, depth perception and eye-hand
coordination.
449 Manual radionuclide applicator Intended to apply a radionuclide source into the
system body or to the surface of the body for radiation
therapy.
450 Manual stander A manually-powered, mobile device designed to
support and lift a disabled patient to an upright
standing position to provide the health benefits
associated with standing (e.g., improved breathing,
circulation, and flexibility); it is not intended to
facilitate gait.
451 Manual toothbrush An instrument designed to be used by a patient to
manually brush clean their teeth and gums (i.e.,
remove plaque, tartar, stains, etc) and/or aid in
prevention of dental disorders such as caries.
452 Manual wheeled stretcher Intended to transport patients in a horizontal position
as an assistance to injury or disability.
453 Manual-aperture-control diagnostic A standard, non-motorized, diagnostic x-ray beam-
x-ray system collimator, non- limiting device whose aperture size/length/shutter
motorized assembly must be manually adjusted in order to
match the size of the x-ray beam to the size of the x-
ray cassette in use. An x-ray collimator is used to
limit the effects of scattered radiation on image
quality and to provide patient protection by
eliminating exposure to non-target body areas.S.No. Device Name Intended Use
454 Marker, dental use This device range helps mark plaque areas on a
tooth and is thus intended to be used to aid
disclose/make marks that allows identify dental
plaque.
455 Mask strap A head strap used to hold and stabilise a CPAP or
BiPAP face mask onto a patient's face.
456 Massage table/couch Intended for supporting body during therapeutic
massages (not intended for general wellness
purpose).
457 Maternity belt It is used to support the belly bump during the
different prenatal periods to avoid forward &
downwards stomach pulling, provide maximum
support and relieve back & pelvic ache.
458 Mechanical dental chair without Intended to support a patient in a seated position to
operative unit facilitate dental examination, treatment, and/or minor
surgery procedures. It does not include operative
unit.
459 Mechanical-resistance external External prosthetic components for the purpose of
ankle-foot external prosthesis replacement for a foot/ankle. The foot/ankle is
intended to be used for a lower limb external
prosthetic system
460 Mechanical-resistance external knee An externally applied component for use in
external prosthesis replacement of the knee joint (or other) in persons
with limb amputation or difference.
461 Mechatronic external ankle-foot The device is intended as a part of an external
prosthesis prosthetic system that replaces the foot and ankle
function of a missing lower limb.
462 Medical compression stockings Intended for management/prophylaxis of leg pain,
deep vein thrombosis, varicose veins and related
complications
463 Medical equipment drape, single- A flexible polymer sleeve designed to form a
use, non-sterile protective water-resistant enclosure around a piece
of medical equipment such as intra-oral cameras
and its equipment components. It is intended as a
hygienic barrier to protect the contents from soiling
and contamination when used in the vicinity of, or
entered into, a hygienic area. It is neither a
dedicated handle cover, device cap nor an
ultrasound transducer cover.
464 Medical examination light (AC Intended for medical purposes that is used to
powered or Battery) illuminate body surfaces and cavities during a
medical examination.S.No. Device Name Intended Use
465 Medical gas terminal unit A device that is a component of a medical gas
pipeline system or a medical gas/vacuum pipeline
system that has a gas-specific outlet connection for
a single/mixture of gas to which the operator can
connect and disconnect a
medica device.
466 Medical image printer A non-invasive, reusable printer that produces hard
copies of medical video images.
467 Medical image storage device Intended to provides electronic storage and retrieval
functions for medical images.
468 Medical image storage device A medical image storage device is a device that
provides electronic storage and retrieval functions
for medical images. Examples include devices
employing magnetic and optical discs, magnetic
tape, and digital memory.
469 Medical imaging recorder A non-invasive, reusable electrically powered device
designed to be used in conjunction with video
endoscopes, and/or surgical video imaging devices
to digitally record video images.
470 Medical instrument cable/lead A reusable cable that functions as a conductor
between power source and the medical instrument
used for the purpose of transmitting an energy that
may, or may not, contain information.
471 Medical print paper Thermal paper to be used to produce hard copy of
printed data generated by a medical device. For
recording the EEG,ECG, EMG output from the ECT
device.
472 Medical support stocking Intended to be worn on the upper or lower extremity
to support, correct, prevent deformity, or to align
body structures for functional improvement.
473 Medical x-ray film, non-screen A non-screen x-ray film specifically designed for use
in medical imaging applications. Non-screen x-ray
film is designed for direct exposure to x-rays and is
relatively insensitive to the visible light emitted from
screens.
474 Medical/cadaver body bags, non Intended for transporting a human corpse without
sterile any spread of biohazard/infectious agent.
475 Medical/Orthotic insoles Intended to be worn inside shoes/footwear to relieve
heel pain, plantar fasciitis, foot pain, pain during
walking, calcaneal spur, sprain and strain of the foot,
ankle, feet and knee pain.S.No. Device Name Intended Use
476 Medicine chamber spacer A device intended to be placed between a nebulizer
or a metered dose inhaler (MDI) and the patient's
mouth, to function as a reservoir into which an
aerosol medication is dispensed in order to minimize
delivery of large aerosolized particles.
477 Medicine cup A specially designed cup used by the nursing staff
when they are administrating tablets or pills to
patients. It may be used both for tablets and fluids.
478 Meibomian gland camera It is an ophthalmic imaging device intended for use
by a physician in adult patients to capture, archive,
manipulate and store digital images of the
meibomian glands.
479 Meibomian gland A non-powered, hand-held manual ophthalmic
expressor/evaluator, manual instrument intended to be used to apply pressure to
the lower eyelid to facilitate natural release and/or
expression of meibomian gland secretions (meibum)
to treat dry eye syndrome.
480 Metatarsal pad Intended to relieve chronic metatarsal pain, corns,
hard skin, morton’s neuroma, forefoot soreness, and
painful balls of the feet.
481 Micropore tape Intended for dressing retention on non-flexing areas
and may also be used for patients who have
exhibited an adverse reaction to adhesives based
upon zinc oxide, rubber, or resin.
482 Microscope cover This is a device which is usually shaped to fit the
surgical camera/microscope that is intended to be
used as a physical barrier to prevent cross-
contamination between staff or patients during
examination.
483 Mirror-prism spectacles Intended to enable the patient to see over the top of
their head enabling them to look forward in the
direction their head is pointing.
484 Mobile radiation protection barrier Intended to protect the operator etc. from
unnecessary exposure to radiation used for medical
diagnosis, treatment and dental procedures.
485 Moist-cold pressure bandage A pressure bandage intended to provide a cool and
to compress a local area of the body.
486 Moldable splint A moldable splint device that is intended for use as
an immobilization of non- or minimally displaced
wrist fractures, contusions, and sprainsS.No. Device Name Intended Use
487 Motorized diagnostic imaging view Intended to retain, retrieve, and project light for
box direct observation of medical images taken using a
variety of methods such as X‐ray, magnetic
resonance (MR), CT, and ultrasound, and recorded
in radiographic film.
488 Mouth gag To be used in dentistry to be placed between the
teeth of a patient in order to maintain an open oral
cavity during dental procedures.
489 MRI enhancement padding Dielectric pads that are intended for use with
magnetic resonance imaging systems to aid in body
positioning and help reduce shading artifacts
associated with the air/tissue interface during
abdominal, pelvic, and neck imaging.
490 MRI examination catheter holder The device is intended to be used with ICP catheter
kits to enable the catheters to be left in during MRI
scanning.
491 MRI phantom, test object Intended for both subjective and quantitative
evaluations of various calibration and performance
characteristics of magnetic resonance imaging
systems and associated image acquisition, display,
and analysis computer programs.
492 MRI system chair A chair or stool specifically designed to support and
position a patient during examinations involving the
use of a diagnostic magnetic resonance imaging
(MRI) system. For MRI system compatibility these
chairs/stools are made of ferromagnetically inactive
materials.
493 Multi-chamber venous compression Deep Vein Thrombosis (DVT) Garments are part of
system garment, reprocessed an external compression system, in which
intermittent or sequential compression is provided
using a pump/controller and limb garment. When
coupled with an appropriate inflation system,
garments are intended for use in preventing deep
vein thrombosis (DVT) as well as the treatment of
edema secondary to venous insufficiency.
494 Multi-modality therapeutic radiation This device is intended to establish and provide for
phantom, test object routine and periodic verification with use of target
motion of patient dose and machine output in
therapeutic radiation oncology system performance.S.No. Device Name Intended Use
495 Multiple spinal region orthosis This is a body worn device that is intended to
provide full circumferential containment when
reduction in gross spinal
motion about the lower thoracic and lumbar spine is
required. This may include post operative spinal
stabilisation, fracture and related soft tissue injuries
496 Nappy changing table, portable Intended to support an infant, child or an adult
during nappy (diaper) changing, or for a patient with
a disability who is incontinent and requires regular
changing of their nappies.
497 Nasal aspirator, electric Intended for superficial use to enable an adult to
gently suction and clear excessive mucus from the
nasal passages of an infant or child to facilitate
easier breathing.
498 Nasal aspirator, manual A portable, hand-held, manual suction device
designed to enable an adult to gently suction and
clear excessive mucus from the nasal passages of
an infant or child to facilitate easier breathing.
499 Nasal dilator Intended to provide temporary relief from transient
causes of breathing difficulties resulting from
structural abnormalities and/or transient causes of
nasal congestion associated with reduced nasal
airflow.
500 Nasal Irrigation kit To cleanse or flush the nasal passages and sinus
cavity with saline for postoperative, preventive, or
symptomatic nasal care.
501 Nasal scissors A surgical instrument used to cut tissue during
surgery on the nose and its associated structures. It
comprises two pivoted blades usually provided with
finger and thumb holes. The distal end of the blades
may be different shapes.
502 Nasal septum straightening forceps Intended to straighten the nasal septum through
grasping and manipulation of the bone/cartilage of
the septum during nasal reconstructive procedures.
503 Nasogastric tube holder This device is intended to secure nasogastric tubes
to skin near and around the nose.
504 Nasogastric tube holder, intranasal The device is used with enteral feeding tubes to
prevent inadvertent removal or displacement of the
tubes for adult patients.
505 Nebulizer tubing set A device intended to be connected to a nebulizer
and transfer medication from the nebulizer to the
patient with respiratory disorders.S.No. Device Name Intended Use
506 Needle guard Intended to encapsulate needles withrawn from vein
or fistula thereby aiding in the prevention of needle
stick injuries.
507 Needle holder Intended to secure needles during suturing.
508 Needle holder, ophthalmology It is intended to hold needle for procedure during
eye surgeries.
509 Neonatal eye pad Used to cover and protect the eye of an infant during
therapeutic procedures, such as phototherapy.
510 Neurosurgical chair Intended to support and position a patient in a sitting
or
reclined position during neurosurgery.
511 Neurosurgical headrests Intended to support the patient's head during a
surgical procedure
512 Newborn-infant bed Intended as support surface to newborn babies.
513 Nipple shield Intended to aid infants with trouble latching onto the
breast by acting like a longer, firmer nipple
514 Non-powered accelerator system Intended to adjust the patient's posture and
table immobilize the patient for radiotherapy.
515 Nonpowered flotation therapy Intended for medical purposes which contains air,
mattress fluid, or other materials, to treat or prevent
decubitus ulcers (bed sores).
516 Non-powered neutron therapy table Intended to adjust the patient's posture and
immobilize the patient for treatment that uses
neutron rays.
517 Non-powered remote irradiation Intended to adjust the patient's posture and
therapy table immobilize the patient for treatment that uses a
remote radionuclide radiotherapy apparatus.
518 Non-powered X-rays radiation Intended to adjust the patient's posture and
therapy table immobilize the patient for treatment using X-ray
radiation therapy
519 Non-rebreathing oxygen face mask A flexible, form-shaped device designed with valve
to control rebreathing and contamination of gas,
placed over the nose and mouth to deliver air of high
oxygen (O2) concentration to a patient's airway for
oxygen therapy.
520 Nose clip It is a device used to help prevent air movement
through
the nose. It is typically used during pulmonary
function tests to ensure that airflow is focused
through the mouthpiece for accurate measurement.S.No. Device Name Intended Use
521 Nuclear scanning bed A nuclear scanning bed is an adjustable bed
intended to support a patient during a nuclear
medicine procedure.
522 Nuclear sealed calibration source A nuclear sealed calibration source is a device that
consists of an encapsulated reference radionuclide
intended for calibration of medical nuclear radiation
detectors.
523 Nystagmus inducing optokinetic Intended to elicit nystagmus.
drum
524 Nystagmus inducing tape Intended to be moved across a patient's field of
vision to elicit optokinetic nystagmus and to test for
blindness.
525 One-piece urostomy bag The ostomy bag is intended to collect output from a
stoma. The adhesive is intended to fix the bag and
adhere to intact skin around the stoma.
526 One-piece urostomy bag, open- The product is intended for the management of
ended stomal output.
527 Operating room shoes cover, non- Intended to be worn by operating room personnel
sterile during surgical procedures to protect foot of both the
surgical patient & the operating room personnel from
transfer of micro-organisms, body fluids, and
particulate material.
528 Operating table traction frame Designed to position, support and/or distract the
patient’s hand, wrist, forearm and arm in a variety of
surgical procedures including, but not limited to
arthroscopic or Orthopedic surgery.
529 Operation theatre pendant Intended to provide ergonomic solution for the
positioning and management of medical devices,
equipment, and utilities during surgeries and other
medical interventions
530 Operator radiation protection Intended to protect the eyes of the operator and
spectacles other personnel from unnecessary exposure to
primary radiation and scattered radiation associated
with diagnosis and treatment.
531 Ophthalmic equipment stand It is used to keep the ophthalmic equipment like Slit
Lamp, Keratometer, Laser etc.
532 Ophthalmic head reflector Intended to reflect light onto the eye of a patient to
allow examination of the eye and its associated
structures.
533 Ophthalmic implant handling forceps, A reusable instrument used to grasp and manipulate
reusable ophthalmic implants (excluding sutures) during a
surgical procedure.
534 Ophthalmic operating table top Intended to provide support for and stabilization of
the head of the patient and to help provide optimal
access for the surgeon(s) during the intervention.S.No. Device Name Intended Use
535 Ophthalmic surgery fluid collection A fluid collection bag connected to a surgical
bag system, used to catch aspirated material during an
ophthalmic surgical procedure.
536 Ophthalmic surgical device handling Intended to grasp and manipulate a nonimplantable
forceps invasive ophthalmic surgical device (e.g., ophthalmic
cannula, handless iris retractor)
537 Ophthalmoleukoscope Intended for testing colour perception by means of
colours produced by polarized light.
538 Opthalmic examintaion station A device assembly intended to provide complete
ophthalmic examination position and support
conditions for the patient and clinician
539 Oral care swab A foam headed oral swab impregnated with a
sodium bicarbonate cleaning solution designed to be
used wet to clean the teeth and oral cavity.
540 Oral exerciser A device that is used to exercise tongue muscles as
part of oral myology physiotherapy
541 Oral medicine dropper Intended for aspirating a small volume of liquid
medicine so that it can be dispensed in single drops
into a patient's mouth, typically an infant or small
child. It is a non-measuring device (non-graduated).
542 Orbital depressor Intended to displace tissue to facilitate examination
of the
surrounding area in the orbital cavity during eye
surgery.
543 Orthodontic aligner/retainer seater, A small cylindrical device intended to aid in
reusable positioning and seating an orthodontic progressive
aligner or teeth retainer into place. This is a reusable
device intended for single-patient use.
544 Orthodontic band pusher A hand-held dental instrument designed for
positioning and adapting metal bands on teeth in
orthodontics.
545 Orthodontic positioner support kit A collection of devices intended to be used to
facilitate use of an orthodontic teeth positioner,
including placement, removal and cleaning.
It typically consists of an orthodontic appliance
remover, an orthodontic positioner seater, and an
orthodontic appliance cleanser. The positioner is not
included. This is a single-patient device.S.No. Device Name Intended Use
546 Orthodontic resin positioning tray A custom-made dental device in the form of a
patient’s dentition which contains cavities intended
to hold and facilitate positioning of light-cured dental
resin onto teeth for subsequent attachment of an
orthodontic appliance (e.g. aligner) after curing.
547 Orthodontic spring The intended purpose of the orthodontic spring is to
open and close space between teeth.
548 Orthodontic vibrator Orthodontic predictability enhancement device
designed to maximise the accuracy of fit and
effectiveness of clear aligner treatment.
549 Orthopaedic bed Intended to provide support for skeletal traction to
stabilize fracture sites.
550 Orthopaedic bone pin holder A non-sterile stainless steel cylindrical device
intended to temporarily hold one or more
orthopaedic pins (e.g K-Wires) during sterilisation &
surgical procedure against damage.
551 Orthopaedic countersink used for bone preparation to enable the placement
of gingival part of components during dental
procedures in the mouth.
552 Orthopaedic instrument extractor A reusable surgical instrument designed to extract
another orthopaedic instrument during an
orthopaedic surgical procedure.
553 Orthopedic cast padding It is intended to protect long prominences under the
plaster on intact skin .
554 Orthopedic walker shoes/boots/Air Intended for the treatment and rehabilitation of foot
cast boots and ankle injuries and to provide support, stability,
and protection to the foot and ankle during the
healing process in cases of fractures, sprains, post-
surgery, or severe foot or ankle injuries.
555 Ostomy adhesive Adhesive to be placed around stoma to attach 2
piece ostomy collection device.
556 Otoscope cover A disposable ear specula is a plastic cover which fits
onto an otoscope to form a physical barrier
protecting patients against cross contamination.
557 Otoscope, direct Intended for examination of the outer ear canal and
tympanic membrane (eardrum) by direct viewing
through the ear opening.
558 Otoscope, endoscopic Intended to be used in otology mainly for
observation, diagnosis, and treatment of the outer
and/or middle ear.
559 Oxygen administration hood Intended to provide an enriched oxygen (O2)
environment to increase the patient's O2 uptake.S.No. Device Name Intended Use
560 Oxygen administration hood, Intended to be used as an enclosure over an infant's
paediatric whole body, or the head only, in order to provide an
enriched environment of oxygen (O2) to increase the
patient's O2 uptake.
561 Oxygen administration tent, Intended to cover the bed of a neonatal or small
neonatal/paediatric child to provide an enriched environment of oxygen
(O2) to increase the patient's O2 uptake. It is used
for the treatment of breathing disorders in infant and
paediatric patients permitting them movement
without restriction.
562 Oxygen mask respiration indicator Designed to be attached to the exhalation vent hole
on the exterior of a standard oxygen face mask and
provide visual indication of patient respiration.
563 Pacemaker test magnet Intended to test an inhibited or triggered type of
pacemaker pulse generator and cause an inhibited
or triggered generator to revert to asynchronous
operation.
564 Packer, gauze To be used in dentistry and dental surgery for
introducing and packing gauze or dressings into
cavities.
565 Paediatric dorsiflexion slant board It is intended to be used in the treatment of various
medical conditions (e.g., congenital, neurological,
post-traumatic) where tendon tightness and muscle
contracture affect the ability to dorsiflex the foot,
possibly leading to an abnormal gait.
566 Panniculus skin-adhesive retractor, This retractor is intended to be used on intact skin
reusable for positioning redundant tissue (i.e., post c-section,
post laparotomy) away from the lower abdominal
incision/wound.
567 Parallel bar exerciser Intended to assist users in maintaining good walking
posture, particularly a person with a disability, a
paraplegic, or a patient who has suffered a stroke
and is learning to walk.
568 Parapodium walking frame Intended to encompasse and provide support for the
body of a patient who is unable to stand unassisted
to help them move (walk) by changing their centre of
gravity (COG).
569 Partial hand radiation protector Intended to protect part of hands and fingers from
unnecessary exposure to primary radiation and
scattered radiation associated with diagnosis and
therapeutic measures.
570 Patient audiovisual communication It is intended for use by trained personnel in
system functional, interventional and clinical MRI
environments to facilitate audio communications
during a scanning session.S.No. Device Name Intended Use
571 Patient enclosure system A freestanding, framed, tent-like structure designed
to be constructed on-site to function as a temporary
enclosure for safe playing, resting or sleeping,
typically for a patient with autism, epilepsy,
challenging behaviours and/or learning difficulties. It
has a soft fabric/plastic interior with padded regions
to prevent injury, and a limiting and low-stimulation
environment.
572 Patient gown, non-sterile Intended to be worn by patients in a clinical setting
(e.g., during hospitalization, during examination in a
doctor's office).
573 Patient holder The device is used to support patient's trunk and or
lower limbs into a more symmetrical position. The
intended patient group are those with disabilities
who require assistance to maintain an optimal
position, therefore preventing secondary
complications such as joint contractures, pressure
areas and pain.
574 Patient isolation tent canopy A non-sterile covering designed to be used with a
frame to provide environmental isolation of a
contagious patient to protect hospital personnel and
other patients from exposure to non-airborne
infections (e.g. diphtheria, meningococcus) whilst
the patient is being treated.
575 Patient lift Intended as an assistive device to lift and transfer a
patient with limited mobility from one place to
another.
576 Patient transfer board Intended to reduce the friction and difficulty during
the task of moving or transferring a patient from a
surface to another e.g. Bed to stretcher and reduce
risks associated with manual handling by the staff
577 Pedal exerciser Intended for exercise therapy for upper and/or lower
body.
578 Pediatric gait trainers Intended to assist and train children unable to walk
or stand independently to enhance movement and
independent ambulation
579 Pelvic floor exercise biofeedback It is intended for encouraging regular pelvic floor
device exercises; strengthening of the pelvic floor muscles;
rehabilitation and training of weak pelvic floor
muscle; treatment of stress, urge and mixed urinary
incontinence in women; improving sexual pleasure
or function in women with existing pelvic floor
dysfunction; improving pelvic floor function in the
post-partum period; improving mild to moderate
prolapse symptomsS.No. Device Name Intended Use
580 Pelvic traction kit (with/without Intended to apply uniform and controlled traction to
weights) the lumbar, sacral, and thoracic areas of the
vertebral column.
581 Pen torch Intended to assist with examinations by illuminating
regions of the eye mount or ear.
582 Percussion hammer, manual Intended to be used by an examining physician to
gently tap near a patient's joints to test reflexes.
583 Periodontic hoe A hand-held manual dental instrument with a small
blade at an acute angle (e.g., 90 degrees) to its
stem intended to be used with a pulling action to
remove gross amounts of supragingival calculus,
and some subgingival calculus, in large wide-open
pockets where the gingival tissue is soft and easily
cleaned.
584 Philadelphia collar (cervical) Intended to be used in cervical fracture to support
neck bones and ligaments by restricting the
movement of the neck muscles
585 Phoropter arm Used to mount the phoroptor during an ophthalmic
examination; typically to mount the phoroptor to
determine a patient's prescription for glasses.
586 Phototherapy eye protector, reusable Intended to cover and protect the eyes of a patient
or user from potentially harmful rays [e.g., ultraviolet
(UV)] to which parts, or all, of their body is
intentionally exposed during light therapy treatment.
587 Phototherapy eye protector, single- Intended to cover and protect the eyes of a patient
use from potentially harmful rays [e.g., ultraviolet (UV)] to
which their body is intentionally exposed during light
therapy treatment.
588 Phototherapy infant blanket A piece of fabric, made from ultraviolet (UV) light
transmittable material, intended to be used to wrap a
newborn/infant during UV phototherapy for the
treatment of neonatal jaundice (neonatal
hyperbilirubinemia) to enable therapeutic light to
pass through to the patient while simultaneously
providing comfort. It does not include a light source.
589 Physical restraint Intended to secure patient to chair, wheelchair, bed
etc. to prevent self-harm or injuries to the health
care professional handling the patientS.No. Device Name Intended Use
590 Physical therapy table, line powered Intended to facilitate functional training of
patients/subjects with loss of lower extremity, upper
extremity or core functionality, caused by conditions
of orthopedic, musculoskeletal, neurological, or
other origin by providing muscular load in
combination with visual feedback.
591 Physio Motion Therapy BTL-CP Intended to be used during the first phase of
Motion rehabilitation following lower limb joint surgeries or
traumas.
592 Picture archiving and communication A device intended for the recording, viewing,
system presentation and storage of digital still frames and
video sequences for use with a microsurgical
operating system.
593 Pill crusher/splitter A hand-held device used for crushing or splitting
medication in the form of a tablet for easier ingestion
by a patient who cannot swallow the tablet whole.
594 Pinwheel Intended for testing pain sensation
595 Plaster instruments/plaster saw A instrument used to cut or shave or put plaster.
596 Plaster of Paris bandage It is intended for support of fractured body part.
597 Plaster spreader used to separate and spread hardened plaster
598 Pleoptophor Intended for use during the treatment of eccentric
eye fixation (casts in the eye) by dazzling the
perimacular retina, thereby relatively enhancing the
visual capabilities of the fovea.
599 Pneumatic external knee joint Intended to replace knee joint in persons with lower
limb amputation and connecting to above knee
prosthesis
600 Pneumatic stander Standing aid chair for Disabled Person
601 Pneumatic tourniquet and its Used for stopping flow of blood through artery by
attachment compression.
602 Pneumatic walker To provide pneumatic compression and support to
the ankle joint.
603 Polatest Intended for evaluating hidden (latent) squinting, i.e.,
when the patient is not aware of the condition, and
also when it cannot be seen.
604 Portable system mount Intended to be fixed vertically within a clinical setting
to enable the easy and secure mounting of a
portable medical device.S.No. Device Name Intended Use
605 Positioning aid system A mattress system specifically designed for the
disabled person allowing various positions to be
maintained with the aid of positioning aids. designed
to allow air flow to reduce sweating/heat and
therefore the possibility of spasm.
606 Positron camera A positron camera is a device intended to image the
distribution of positron-emitting radionuclides in the
body.
607 Postpartum maternity belt It is intended to help reduce swelling, provide
support to the lower back and abdominal muscles,
and promote healing after delivery.
608 Postsurgical head/neck garment It is a wearable contoured cranial cover intended for
the restoration or augmentation of cosmetic
appearance in patients with bony defects of the
cranium.
609 Postsurgical transparent eye shield, A device designed to be worn over the eye to protect
vented the eye while allowing the wearer to see, typically
following ophthalmic surgery. It is designed as a
transparent self-adhesive dome which includes vent
holes to allow air to circulate around the eye. This is
a single-use device.
610 Power wheelchair Intended to aid in mobility of individuals with
physical disability, lack of senses in lower
extremities and having difficulty in walking.
611 Power-assisted foot/hand-propelled Power assisted foot/hand propelled tricycle designed
tricycle specifically for people with disabilities
612 Prescription spectacles An ophthalmic device consisting of a spectacle
frame with a pair of optical spectacle lenses
(typically made of plastic or glass, also known as
eyeglasses) designed to be worn in front of the
user's eyes to provide refractive corrections to
eyesight conditions such as presbyopia (the eye's
diminished power of accommodation that occurs
with ageing), or refractive ametropia (myopia,
hyperopia and astigmatism). The lenses may be
tinted (sunglasses) to protect the eyes from bright
light and radiation.
613 Professional examination gown, non- Intended to be worn by healthcare providers,
sterile sometimes over scrub suits, while examining
patients to protect both the patient and staff from the
transfer of contaminants such as microorganisms or
body fluids.S.No. Device Name Intended Use
614 Prophylaxis cup/ Dental polishing This is a device that is intended to be used as a
cup polishing cup to apply polishing agents during dental
prophylaxis (cleaning). The device is held in a dental
handpiece.
615 Proprioceptive nest Intended to give physical support to the preterm
newborn. It is designed to provide preterm babies
with age-appropriate proprioceptive stimulation as
well as comfort, a sense of security, and tactile
stimulation.
616 Prosthetic external arm Intended to be used as an external prosthesis for
upper limb distal to shoulder joint by patients with
upper limb loss or deficiency.
617 Prosthetic external foot (Winged Intended for persons with a lower-limb amputation to
Foot) restore lost mobility
618 Prosthetic foot, pediatric Intended for children with a lower-limb amputation to
restore lost mobility
619 Protective garment for Incontinence Intended to protect an incontinent patient's garment
from the patient's excreta.
620 Psychophysiological biofeedback Intended to improve certain medical conditions
system through user interaction, including anxiety,
depression, pain, loneliness, mood and/or
motivation; and for symptoms such as agitation,
aggression, walking about found in some mental
health disorders and/or neurocognitive disorders
such as dementia.
621 Pulmonary equipment filter Intended to prevent biological contaminants from
entering pulmonary function testing equipment to
help protect the patient and equipment during lung
function tests.
622 Pulmonary exerciser The device is a handheld device that is intended to
improve expiratory/exhalation and
inspiratory/inhalation muscle strength for the
enhancement of breathing, coughing, swallow, voice
and fitness.
623 Pupillograph Intended for recording the response of the pupil to
reflected light for ophthalmic diagnostic purposes.
624 Radiation face protector Intended to protect the face and eyes of medical
personnel and other personnel from unnecessary
exposure to primary radiation and scattered
radiation associated with diagnosis and treatment.
625 Radiation protection apron Intended to protect the patient, the operator, and
other personnel from radiation exposure during a
medical or dental procedure.S.No. Device Name Intended Use
626 Radiation protection blanket Intended to protect specific body parts of the patient,
operator, and other personnel from unnecessary
radiation exposure in medical/dental procedures for
diagnosis and treatment.
627 Radiation protection cap Intended to protect the head of the operator and
other personnel from unnecessary exposure to
primary radiation and scattered radiation associated
with medical procedures for diagnosis and
treatment.
628 Radiation protection collar Intended to protect the neck or thyroid of the patient,
the operator, and other personnel from unnecessary
radiation exposure in medical/dental procedures for
diagnosis and treatment.
629 Radiation protection gloves Intended for complete protection of the hands of the
operator and other personnel from unnecessary
exposure to primary radiation and scattered
radiation associated with diagnosis and therapeutic
measures.
630 Radiation protection goggles Intended to protect the eyes of the operator and
other personnel from unnecessary exposure to
primary radiation and scattered radiation associated
with medical/dental procedures for diagnosis and
treatment.
631 Radiation protection mitten Intended to protect the hands of the operator and
other personnel from unnecessary exposure to
primary radiation and scattered radiation associated
with diagnosis and therapeutic measures.
632 Radiographic ECG/respirator A radiographic ECG/respirator synchronizer/X-ray
synchronizer/X-ray synchronizer synchronizer is a device intended to be used to
coordinate an x-ray film exposure with the signal
from an electrocardiograph (ECG) or respirator at a
predetermined phase of the cardiac or respiratory
cycle.
633 Radiographic film illuminator/X-ray A radiographic film illuminator is a device containing
LED view panel a visible light source (e.g., LED) covered with a
translucent front that is intended to be used to view
medical radiographs.
634 Radiographic film marking A radiographic film marking system is a device
system/radiographic film marker intended for medical purposes to add identification
and other information onto radiographic film by
means of exposure to visible light.S.No. Device Name Intended Use
635 Radiographic film processor, It transports dental x-ray film from one solution to the
automatic next in the film developing process without any
manual labour except the insertion of the
film/cassette.
636 Radiographic film, non-screen Intended to record images during diagnostic
radiologic procedures.
637 Radiographic grid/X-ray grid/Anti- A radiographic grid is a device that consists of
scatter grid alternating radiolucent and radiopaque strips
intended to be placed between the patient and the
image receptor to reduce the amount of scattered
radiation reaching the image receptor
638 Radiographic head holder Intended to position the patient's head during a
radiographic procedure.
639 Radiographic intensifying screen It is used to reduce the X-ray dose to the patient and
to allow for shorter exposure times to reduce motion
artefact on exposed film.
640 Radiographic/X-ray cassette holder Intended to be used as a support to hold and
(wall-mounted/ceiling mounted/floor position radiographic cassettes for a radiographic
standing) exposure for medical use.
641 Radiologic patient cradle Intended to be used for rotational positioning about
the longitudinal axis of a patient during radiologic
procedures.
642 Radiologic table Intended for medical purposes to support a patient
during radiologic procedures.
643 Radiological breast positioning The device is indicated to aid in supporting
device, wearable adolescent and adult patients undergoing radiation
therapy including electron, photon, and proton
treatments. The device is also used during image
acquisition to support treatment planning.
644 Radionuclide test pattern phantom A radionuclide test pattern phantom is a device that
consists of an arrangement of radiopaque material
sealed in a solid pattern intended to serve as a test
for a performance characteristic of a imaging
device.
645 Rebreathing oxygen face mask Intended to be placed over the nose and mouth to
deliver a proportional mixture of air/oxygen (O2) to a
patient's airway.
646 Reciprocating walking frame Intended to be used a walking aid by people with
physical disabilities or poor balance
647 Reclining wheelchair A walking aid that reclines enabling the person to
change positions from sitting to lying down.S.No. Device Name Intended Use
648 Recording paper This device is specially produced paper intended to
be used for recording the output of devices
measuring physiologic parameters, e.g.
electrocardiogram (ECG), electroencephalogram
(EEG) or ultrasound imaging or for recording fetal
images.
649 Rectal dilator Intended to dilate the anal sphincter and canal when
the size of the anal opening may interfere with its
function. This is a single-patient use device and is
intended for transient use.
650 Rectoscope/proctoscope handle Intended to be used as a handle to hold a
rectoscope or proctoscope during an examination
procedure.
651 Rectosocope/proctoscope handle Intended to be fitted to the proximal end of the
end-cap handle of a rectoscope or proctoscope during an
examination procedure to provide an airtight seal so
that air can be pumped through the scope to
inflate the bowel.
652 Rescue blanket Intended to keep a person warm and/or to prevent
the further loss of body heat in emergency/rescue
situations.
653 Retractor holder Intended for mounting of surgical retractors.
654 Reverse-image mirror, dental A device designed to be placed at the back of the
teeth while taking image for dental examination
purposes.
655 Rib belt Intended for providing support and compression to
the ribcage and relief from rib pain and discomfort,
especially after injuries or surgeries, supporting
breathing and coughing during recovery, and
preventing rib injuries in certain sports or physically
demanding professions.
656 Rod cutter/reducer Intended to be used to reduce or seat an
implantable rod into the saddle of the implant.
657 Rollator Intended as a walking aid for balance and stability in
individuals with limited mobility.
658 Rongeur, dental To be used in dental surgery to remove hard or
tough body tissues such as cartilage or bone, by
applying a biting/cutting action. This is a reusable
device.
659 Rotating vestibular chair A tilting and rotating chair intended to be used in
clinical procedures for testing vestibular-ocular
disorders.
660 Scalpel blade remover, non sterile Intended to assist the removal of used/blunt blades
from a scalpel handle during a surgical procedureS.No. Device Name Intended Use
661 Scintillation (gamma) camera A scintillation (gamma) camera is a device intended
to image the distribution of radionuclides in the body
by means of a photon radiation detector.
662 Scoop stretcher Intended to transfer a trauma patient and reduce the
chance of undesirable movement of injured areas.
663 Shaped ankle wedge prosthesis, Intended to be used as external artificial joint that is
adult designed to replace the ankle joint in adults
664 Shaped ankle wedge prosthesis, Intended to be used as external artificial joint that is
pediatric designed to replace the ankle joint in children
665 Shield, resuscitation To minimise tissue contact and exchange of fluids
between parties during mouth to mouth
resuscitation.
666 Shoulder immobilizer Intended to temporarily immobilize or limit abduction
of the shoulder joint to support healing of an injury or
a surgical wound.
667 Shoulder wheel It is a device that allows patients to perform
resistance exercises to improve range of motion and
relieve pain (intended for hospital use)
668 Silicone prosthetic ear Intended to adhere to the skin as an artificial
external ear using safe, biocompatible glue for
patients born with microtia and other birth
differences such as Treacher Collins or Goldenhar
syndrome; as well as those who have suffered
traumatic injury or undergone cancer resection
surgery.
669 Silicone prosthetic nose Intended to restore normal contour and improve
function for patients who have experienced partial or
total loss of their nose to traumatic injury, disease or
due to surgical removal of the nose (rhinectomy).
670 Single use binocular indirect lenses Intended for visualization of the human retina
(fundus) using a binocular indirect ophthalmoscope.
671 Single-chamber venous compression Deep Vein Thrombosis (DVT) Garments are part of
system garment, reprocessed an external compression system, in which
intermittent compression is provided using a
pump/controller and limb garment. When coupled
with an appropriate inflation system, garments are
intended for use in preventing deep vein thrombosis
(DVT) as well as the treatment of edema secondary
to venous insufficiency.S.No. Device Name Intended Use
672 Sitz bath Intended for use in external hydrotherapy to relieve
pain or pruritus and to accelerate the healing of
inflamed or traumatized tissues of the perianal and
perineal areas.
673 Sitz bath chair Intended to support a person in sitting position for
external hydrotherapy to relieve pain or pruritus and
to accelerate the healing of inflamed or traumatized
tissues of the perianal and perineal areas.
674 Skin abrasion device/file Intended for debridement of thickened nails and
callus.
675 Skin adhesive protective material Intended to protect healthy skin from friction during
removal of tapes and films. It provides a thin
protective layer on the skin and helps tape and film
adhesion.
676 Skin marker guide A non-sterile device intended to be used as a guide
to create markings on the skin surface with a
drawing skin marker, typically to outline a surgical
incision site or for dermatology applications. It is
typically shaped specifically for its intended
application.
677 Skin marking transfer paper A non-sterile, non-invasive device intended to
transfer a grid of ink dots onto the skin surface to
assist a clinical procedure. This is a single-use
device.
678 Skin pressure protectors Intended to reduce pressure on the skin over a bony
prominence to reduce the likelihood of the patient's
developing decubitus ulcers (bedsores)
679 Skin-cover sealant/Synthetic polymer This is a non-cytotoxic cyanoacrylate based liquid
liquid barrier cream skin barrier film for the skin to form a transparent
flexible film to prevent skin irritation caused by
moisture eg. urine, friction from bedding and by
adhesive products.
680 Slit Lamp Intended to be used as a specialized magnifying
microscope to examine the structures of the eye
(including the cornea, iris, vitreous, and retina).
681 Snoring sensor Intended for use in the detection of snoring, muscle
movement, respiratory effort and/or airflow.
682 Soft dental reliner Intended to be used as a tissue conditioner and a
reliner for short term use for removable dentures. It
may be intended for professional and/or home use.
683 Soft rehabilitation glove Intended for rehabilitation training of patients with
finger joint dysfunction.S.No. Device Name Intended Use
684 Solid-ankle-cushion-heel (SACH) Intended for persons with a lower-limb amputation to
foot restore lost mobility
685 Spatula An instrument, usually made of stainless steel,
which is used to spread a material on a surface, to
fill material into a cavity, manipulate tissue or to
remove a material from a surface. This is a reusable
device.
686 Spine orthosis An externally-applied wearable appliance intended
to support and correct deformities of the spine. It
may be one of numerous different designs and is
typically made of synthetic and textile materials. This
is a single-patient reusable device.
687 Stair chair Supports and transports a patient occupant in a
seated position up or down a set of stairs.
688 Standing wheelchair Intended as a walking aid that allows users to raise
themselves in upright position using upper limbs
689 Steam inhaler Intended for the inhalation of steam for the relief of
the symptoms (congestion and pressure) associated
with upper respiratory disorders.
690 Sterilization/disinfection containers Intended to hold wrapped and/or unwrapped
medical/dental devices in a chemical
washer/disinfector and/or sterilizer during the
washing/disinfection and/or sterilization cycle(s).
691 Sterilizer/disinfector rack A non-sterile rack intended to hold medical devices
in a steriliser or chemical washer/disinfector during
the sterilisation or washing/disinfection cycle. It may
also be used to transport medical devices to and
from the process and for their storage. This is a
reusable device.
692 Sternal binder Intended to stabilize and support the sternum after
sternotomies
693 Stress exercise trolley This treadmill is intended to be used for cardiac
stress testing.
694 Suction system filter, non sterile A filter used with a suction system to separate tissue
from the fluid waste collected from a medical
procedure.
695 Surgical binoculars Intended to be mounted onto a surgeon's spectacles
to function as small telescope and provide a
magnified image of the visual field during patient
examination or surgical intervention.
696 Surgical camera and accessories Intended to be used to record operative procedures.S.No. Device Name Intended Use
697 Surgical camera holder Intended to hold and position a camera, or camera
system and/or other devices during surgical
procedures.
698 Surgical cap, non-sterile Intended to protect face of patient & the operating
room personnel from the transfer of micro-
organisms, body fluids & particulate material.
699 Surgical eye pressure shield A non-sterile device intended to cover and
mechanically protect the eyes of a patient during
surgery to prevent potential ocular pressure
hazards/injury associated with surgery (e.g.,
resulting from inadvertent pressure being applied to
the eye by healthcare professionals, equipment, or
due to the orientation of the patient).
700 Surgical guillotine Intended for severing tissue as a means to prevent
infection/drainage of infected site
701 Surgical helmet, non-sterile Intended to protect healthcare workers from
contaminants & debris on head.
702 Surgical implant handling forceps A hand-held manual surgical instrument with blades
designed to grasp and manipulate a surgical implant
(excluding sutures) during implantation; it is not
intended for use on tissues, is not a dental or
ophthalmic device, and is not a dedicated tissue clip
applier. This is a reusable device intended to be
sterilized prior to use.
703 Surgical instrument assist arm The device assists in maintaining spatial positioning
system of instruments during surgical procedures
704 Surgical instrument holder, reusable device intended to be used in the operating room
(OR) by staff to safely contain a delicate or sharp
hand-held, manual, surgical instrument(s)
705 Surgical instrument rack Intended for the safe storage and counting of used
sharps during and prior to the the end of a surgical
procedure. The used sharps are held in place by
foam, magnet or other mechanisms and the device
can be closed securely for safe sharps disposal.
706 Surgical knee cover Reusable surgical cover used as a protective cover
to protect the patella during knee surgery.
707 Surgical lamp Intended to provide visible illumination of the
surgical field or the patient.
708 Surgical lamp (ophthalmic) Intended to serve as a cold light source for
illumination of the intraocular posterior segment in
optical surgery in case of vitrectomies.S.No. Device Name Intended Use
709 Surgical lens (camera accessory) A device designed to be used with a camera, or a
camera system being used during medical
procedures.
710 Surgical light/illumination system/OT Intended to providing optimal light and colour
lights rendering to aid surgery.
711 Surgical material compression A reusable manual instrument intended to flatten
device material, such as tissue, for use in a surgical
procedure (e.g., tympanoplasty) after it has been
flattened.
712 Surgical microscope and Intended for use during surgery to provide a
accessories magnified view of the surgical field.
713 Surgical sleeve cover, non-sterile It is a forearm covering made of non-woven
synthetic fabric materials intended to be worn over a
scrub suit by healthcare staff during procedures to
maintain hygiene and prevent cross-contamination
of microorganisms, body fluids, and particulate
materials between the patient and staff.
714 Surgical torque wrench adaptor This is a hand held component of a surgical wrench
that is intended to connect to the main body of the
wrench to a variety of distal end pieces (bits) and
assist with the use of a torque wench in the mouth
during a dental procedure.
715 Surgical trays Intended to provide a suitable platform for general
containment of many medical/surgical instruments
and related items during a clinical procedure.
716 Surgical video camera A video camera used to generate video images of
surgical procedures, which are fed to a monitor
screen for local or external viewing.
717 Swivel-walker Intended to encompasses and provide support for
the body of a patient who is unable to stand
unassisted, to help them move (walk) by rocking
sideways (shifting their weight from side-to-side with
a shoulder movement).
718 Synoptophor Intended for the evaluation and training of a patient's
binocular function.
719 Tachistoscope Intended to flash words or images at different
speeds, for the purposes of ophthalmic diagnostic
testing.
720 Tearable adhesive plaster It is intended to secure dressings and for strapping
on intact skin.
721 Tearable adhesive tape It is intended to secure dressings and for strapping
on intact skin.
722 Teething device, non- fluid-filled Intended to be bitten by a patient (infant or adult) to
soothe gums during the teething process.S.No. Device Name Intended Use
723 Tester, colour discrimination Devices for colour vision testing
724 Testicular temperature regulation This is a garment that is body worn that is intended
underpants to be placed around the pelvic region in the same
manner as conventional male underwear that is
designed to keep the testicles cool for increased
spermatogenesis, as part of an fertility treatment,
through ventilation features (e.g., breathable mesh)
that prevent excessive insulation of the testes.
725 Therapeutic medical binder, general Intended for medical purposes and that can be
purpose secured by ties so that it supports the underlying
part of the body or holds a dressing in place like
abdominal, breast and perineal binder.
726 Therapeutic scrotal support Intended for medical purposes to support the
scrotum (the sac that contains the testicles)
727 Thermographic camera It is a thermal based imaging device, intended for
viewing and digitally storing thermal patterns
generated by the human body in a clinic, hospital,
acute care setting, surgery, healthcare practitioner
facility or in any environment where healthcare is
provided by a qualified healthcare professional.
728 Thermoplastic mask for Intended to immobilize the patient to deliver the
immobilization correct Radiation dose
729 Thumb spica splint Intended to minimize movement and provide support
and comfort by stabilizing an injury of the thumb
730 Toe separator Intended to space the toes of the foot to relieve pain,
pressure/friction between toes, and/or to facilitate
realignment of the toes to a natural position.
731 Tongue depressor Intended to move the tongue to facilitate
examination of surrounding organs and tissue.
732 Tongue scraper A device used to scrape the upper surface of the
tongue to promote oral hygiene (e.g., to remove
plaque, food debris, and bacteria, and to prevent
bad breath). It may be single use or reusable and is
an OTC device.
733 Tongue-retaining sleep-disordered A removable intraoral device designed to alleviate
breathing orthosis sleep-disordered breathing conditions (e.g., snoring,
obstructive sleep apnoea) by retention of the tongue,
frequently keeping the tongue in a forward position
during sleep.S.No. Device Name Intended Use
734 Tracheal surgery dilator Intended to be used during surgical intervention of
the trachea to dilate tracheal structures/passages,
typically during the creation of a tracheostoma
and/or for expanding the margins of a tracheostoma
to assist in the insertion of a tracheostomy tube.
735 Tracheostoma protector Intended to absorb secretions and to provide
protection and aesthetic coverage of the
tracheostoma.
736 Tracheostoma shower shield A non-sterile, waterproof, patient-worn device
intended to cover a tracheal stoma or tracheostomy
tube to prevent inhalation of water during showering.
737 Tracheostomy tube holder Intended to secure a patient’s tracheostomy tube for
use on pediatric (neonates, infants and children)
patients.
738 Tracheostomy tube lubricant Intended to be applied by healthcare staff or a
patient to the outer surface of a tracheostomy tube
inner cannula to facilitate its easy sliding into the
outer cannula.
739 Tracheostomy tube neck holder, To secure a tracheostomy tube by fastening around
single-use the neck of the patient. Composed of cotton/velour
and a velcro fastening.
740 Training aid for communication and Designed for the assessment of disordered voice
speaking and speech, and voice and speech therapy.
741 Training aid for perceptual sense This device is an exercise system that promotes
and co-ordination therapeutic exercises through use of one or more
sensorized movement controllers.
This device is indicated for use by patients with
neurological or other movement impairment,
typically from stroke, who are undergoing
rehabilitation to facilitate muscle re-education,
increased range of motion, or increased
coordination.
742 Transcutaneous electrical stimulation Reusable gel pads that allow electrodes to adhere
electrode adhesive pad gently to the skin.
743 Trial frame A device used in ophthalmic work for holding trial
lenses in front of the eyes during the sight-testing
procedure.
744 Truncal orthosis Intended to support or to immobilize fractures,
strains, or sprains of the neck or trunk of the body.S.No. Device Name Intended Use
745 Tuning fork Intended to test the hearing acuity of a patient, to
diagnose hearing disorders, and to test for vibratory
sense.
746 Ulnar/brachial nerve protector It is use to provide cushioning, support and
protection to elbow and arms during prolonged
surgeries.
747 Ultrasonic coupling gel A coupling medium for ultrasound transmissions.
748 Ultrasonic safety goggle Intended to be worn over the eyes to protect (shield)
the healthcare worker from blood and other body
fluid splashes while performing a clinical or
laboratory procedure.
749 Ultrasonic scanner calibrator It is a block of material with known properties
intended to be used to calibrate ultrasonic scanning
devices
750 Ultrasound imaging phantom, test Intended to provide a standard of reference for
object routine and periodic verification of ultrasound
doppler imaging equipment used for the
identification of disease and pathologies.
751 Ultrasound imaging system table, A non-powered patient table designed to support
non-powered and position a patient specifically for ultrasound
imaging procedures.
752 Ultrasound imaging system table, An electrically-powered patient table designed to
powered support and position a patient specifically for
ultrasound imaging procedures.
753 Ultrasound imaging system A freestanding image processing workstation
workstation specifically designed to be networked with one or
more diagnostic ultrasound imaging systems. It is
typically considered to be a component to a picture
archiving and communication system (PACS) and
does not contain the controls for the direct operation
of the diagnostic imaging system.
754 Ultrasound imaging transducer A unit used to position an ultrasound system
positioning unit imaging transducer that is inserted into the body
through an endoscope. This device is an accessory
to a diagnostic ultrasound imaging system and it
transmits electrical signals that, after processing, will
display the position of a the transducer on a monitor.
755 Umbilical cord clamp Used for clamping the umbilical cord after birth.
756 Umbilical ligator Intended for umbilical cord ligation during surgical
procedures.S.No. Device Name Intended Use
757 Upper limbs gravity-compensating Intended to increase muscle strength, motion in
rehabilitation system different joints and improve motor function in
patients who have lost their function or have
restricted function in their upper extremities.
758 Urinary dilator Intended to dilate the urinary duct
759 Urinary-incontinence A non-sterile, device intended to be inserted into the
vaginal insert, reusable vagina in order to relieve mixed or stress urinary
incontinence in an adult female by providing urethral
support when pressure is transferred from the
abdomen to the pelvic floor area (e.g. upon
coughing, laughing, sneezing, exertion).
760 Urine drainage extension tubing A conduit for urine collection, via a pouch and
tubing, into a gravity drainage collection bottle or
bag.
761 Urological operating table top A component of a modular operating table designed
as a detachable table top to support a patient during
urological examination and surgical procedures,
including cystoscopic procedures and both
transurethral and open surgery of the urinary tract.
762 Urological operating table, A mobile table powered by manually-operated
hydraulic/Transurethral resection hydraulic mechanisms designed to support a patient
table during urological examination and surgical
procedures, including cystoscopic procedures and
both transurethral and open surgery of the urinary
tract.
763 Uterine packer Intended for introducing dressings into the uterus or
vagina.
764 Vacuum cushion Intended for positioning and re-positioning patients’
head & neck, thorax, hip and full body during
radiation therapy and other diseases treatment.
765 Vacuum splint Intended to immobilize and protect injured limbs so
that the patient can be transported safely and easily
in emergency conditions.
766 Vaginal applicator, reusable Intended to apply medication to the vagina.
767 Vaginal applicator, single use A single use device intended to apply medication to
the vagina
768 Vaginal exerciser/Pelvic floor muscle Designed to provide Kegel exercises to strengthen
exerciser and tone the pelvic floor muscle, which in turn
improves conditions such as female incontinence,
sexual dysfunction, prolapse, etc.S.No. Device Name Intended Use
769 Vaginal illuminator A device used to illuminate the vagina during a
gynaecological examination or procedure.
770 Valsalva manoeuvre mouthpiece Intended to be inserted into a patient's mouth to
facilitate performance of the Valsalva manoeuvre.
771 Vice grip Intended to hold pliers during surgical procedures.
772 Video indirect ophthalmoscope Intended as an illumination system to direct
appropriately focused light into the eye in order to
obtain an intermediate image of the fundus (retina)
that is viewed by the observer to diagnose the eye
and record the images and videos of the patient.
773 Video intubation laryngoscope Intended to enable the positioning of the blade into
handle/monitor the oral cavity to manipulate the tongue, preventing
it from obstructing the oropharynx and enabling a
clear view of the trachea for the insertion of an
endotracheal (ET) tube prior to the delivery of
inhalation anaesthesia and/or ventilation.
774 Video laryngoscope adaptor Intended to serve as a connection between the
laryngoscope and the display/monitoring device
during intubation
775 Vision testing/training flipper A device in the form of flipper lenses (two lenses on
either side of a rotatable stem) intended to be used
for the diagnosis and treatment of ophthalmic
accommodation disorders.
776 Vision training software A patient-interactive software package intended to
use visual images (e.g., Gabor patch) to help
improve vision based on noninvasive perceptual
learning therapy (neuro-vision therapy), typically in
patients with amblyopia, or who use corrective
eyewear, or following ophthalmic surgery.
777 Visual chart Intended for use in testing visual acuity.
778 Visual light box Intended for use in testing visual acuity.
779 Visual projector Intended to project an image on a screen to test
visual acuity .
780 Visual field plotter Device for visual field examination
781 Vitrectomy lenses Intended to facilitate the visualization of the retina
during Vitrectomy surgery.
782 Warming chamber A chamber and accessories designed to warm
various items prior to use, e.g. bags of irrigation or
intravenous solutions, blankets, or clothing for
operating theatre personnelS.No. Device Name Intended Use
783 Washers for body waste receptacles Intended for medical purposes that is used to clean
and sanitize a body waste receptacle, such as a
bedpan.
784 Weight activated knee joint external Intended as an artificial knee with a braking
prosthesis mechanism that prevents the knee from bending as
long as the user has weight on the prosthesis
785 Weight-bearing protector for flat The device is a protector for a digital X-ray flat panel
panel x-ray detector/film cassette detector
786 Wheelchair Intended to be used by physically disabled
individuals and old age patients with limited mobility
787 Wheelchair accessory, power A device that can only fulfil its purpose when used
assisted conversion kit together with and to enhance the function of a
wheelchair. It will provide the occupant/assistant
with a powered driving assistance.
788 Wire tensioner Intended to be used during orthopaedic surgery to
apply an appropriate tension to a wire that is being
implanted, usually as part of a system to provide
corrective surgery to the spine. This is a reusable
device.
789 Woven gauze pad, non-sterile A non-medicated, non-sterile device in the form of a
patch or swab (also referred to as a sponge) made
from woven material (e.g., cotton, cellulose) and
primarily designed to absorb fluids for medical
purposes; it does not include petrolatum. It is
typically used to cover/clean superficial wounds or
abrasions and absorb their exudates, absorb body-
surface exudates, or to apply topical medications.
790 Woven gauze roll, non-sterile A non-sterile device in the form of a long strip of
stretchable, absorbent, woven material (e.g., cotton,
cellulose), wound into a roll, and typically designed
for a variety of applications (non-dedicated) such as
a primary wound dressing, dressing retention, injury
padding and compression.
791 Woven gauze roll/sheet A device in the form of a long length of stretchable,
absorbent, woven material (e.g., cotton, cellulose),
wound into a roll or folded, and typically designed for
a variety of applications (non-dedicated) such as a
primary superficial wound dressing, dressing
retention, and injury padding and compression.S.No. Device Name Intended Use
792 Wrist immobilizer Intended to temporarily render the wrist immovable
as therapy for non- displaced fractures, strains,
sprains, and muscle injuries of the wrist.
793 Wrist splint Intended to temporarily render the wrist immovable
as therapy for non-displaced fractures sprains &
muscle injuries of the wrist.
794 Wrist/hand/finger flexion orthosis, An externally applied orthopedic appliance intended
manual to assist in the flexion of the wrist, hand, and fingers
795 Wrist/hand/finger stable-position An externally applied orthopaedic appliance or
orthosis apparatus designed to maintain both the transverse
and longitudinal arches of the hand, and to hold the
thumb in a functional position. This is a reusable
device
796 Wrist/hand/metacarpophalangeal Device is designed to assist in the extension of the
joint extension orthosis wrist, hand, and metacarpophalangeal joints (MP
joints or knuckles)
797 X- ray marker for strut Intended to be used in Six axis correction apparatus
with software.
798 X-ray film cover A small envelope cover used to hold and protect x-
ray films that goes into a patient's mouth
momentarily when taking an x-ray and then
processed.
799 X-ray film magnifying glass A convex lens used for magnifying the details of a
viewed radiograph (x-ray) and shade against strong
interfering light. It can be hand-held or mounted on
the end of an adjustable arm (e.g., a flexible tube or
an articulating arm) which is attached to a stable
base or clamped to a surface worktop.
800 X-ray film processing chemical, A chemical, e.g., a fixer or developer, which is
automatic necessary for automatic processing of x-ray film or
other radiographic films used in, e.g., computed
tomography (CT), magnetic resonance (MR),
ultrasound or nuclear medicine.
801 X-ray film processing chemical, A chemical, e.g., a fixer or developer, used in the
manual manual processing of x-ray film or other kinds of
radiographic film used in medical applications, e.g.,
computed tomography (CT), magnetic resonance
imaging (MRI), ultrasound and nuclear medicine
applications.
802 X-Ray hanger Intended to position and hold the radiograph during
X ray film development, eliminate streaking and
maintain alignment.S.No. Device Name Intended Use
803 Y-Connector (accessory to perfusion Intended to position and hold the radiograph during
sets) X ray film development, eliminate streaking and
maintain alignment.