Classification of Newly Notified Medical Devices to be updated with Classification list of Medical Devices and IVDs

Drugs Controller General (India) Directorate General of Health Services FDA Bhawan, Kotla Road, New Delhi. File No. 29/Misc/3/2017-DC (292) Date: 15.05.2019 Notice Classification of newly notified Medical Devices Notified S. No. Intended Use Risk Class Category Use of x-ray source and digitally scanned Class C CT scan computer technology to create cross-sectional 1. Equipment images of the body. It is a medical imaging procedure using radio MRI waves, magnetic fields, and magnetic field Class C 2. Equipment gradients to generate images of organs in the body. It is a device that automatically analyzes the rhythm of heart of cardiac arrest patients and Defibrillators Class C 3. delivers an electrical shock to the heart for restoring the normal rhythm of heart. It is used for acute or chronic kidney failure that Dialysis filters blood to remove excess water and waste Class C 4. Machine products. Intended to detect the gamma radiation and PET positron emitting radionuclides in the body and Class C 5. Equipment produce cross-sectional images which reflect the distribution in the body or individual organs. Use of X-rays to diagnose or treat patients by X-Ray Machine imaging the internal structure of the body to Class C 6. assess the abnormalities in the body. It is a general lab equipment to be used to isolate Bone marrow target cells and cells concentrate from bone and Class B 7. cell separator blood.It is device used to administer medications in the Nebulizer Class C 8. form of mist to inhale for respiratory disorders. Blood Pressure It is device used to measure the diastolic and Monitoring Class B 9. systolic blood pressures. Devices Digital It is device used to record the body temperature. Class B 10. Thermometer It is a device used to measure the concentration *Glucometer Class C 11. of glucose in blood. Organ Solution for hypothermic flushing, storage and Preservative transport of organs and to maintain the organ Class C 12. Solution vitality during transplant into human recipients. * Glucometer will be regulated under IVD categoryNotice File No. 29/Misc/3/2018-DC(18) Date: 16.08.2018 In continuation to the earlier Notice vide File No: 29/Misc./3/2017-DC(292) dated 01.11.2017 and amended classification list dated 06.06.2018 regarding Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017, the following Medical Devices have been added in the annexure I : S. No. Notified Category Device name General Intended Use Risk Class 1. Surgical Dressings Suture Anchor Soft Tissue Repair C (Spartan PEEK Suture Implant) 2. Disposable Special bevelled Power - injectable safety non-coring C Hypodermic Needles needles for implantable needle is a device intended for insertion vascular access system into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. It is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the needle is also indicated for power injection of contrast media. 3. Internal Prosthetic Auditory Brainstem An auditory brain stem implant is a D Replacements Implant System small device that is surgically implanted in the brain of a deaf person whose auditory nerves is lacking or damaged. The auditory nerves conduct the sound signals from the ear to the brain. The implant enables otherwise the deaf people to have a sensation of hearing. 4. Surgical Dressings Sternal fixation Sternal Fixation System is intended for C Reconstructive implant use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. 5. Internal Prosthetic Dural Graft Implant Dural Graft Implant is intended for use C Replacements in procedures where the repair orsubstitution of the patient’s dura mater is needed. 6. Catheters Implantable infusion Intended to treat chronic pain and D pumps with Catheters spasticity patients. The pump is inserted below the ribs and it designed to continually transport medication to the site of action. Doses are accurate, user friendly and the device does not restrict movement. 7. Catheters Laser Sheath Intended for use as adjuncts to C conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation 8. Internal Prosthetic Gluteus implants Implant for augmentation of buttocks C Replacements 9. Internal Prosthetic Calf implants Implant for augmentation of Calf C Replacements 10. Blood Bags Blood bags without It is indicated for the collection of C anticoagulant human blood and the preservation of blood components. 11. Blood Bags Blood bags with It is indicated for the collection of C anticoagulant human blood and the preservation of blood components. 12. Catheters Trocars A trocar is made up of B an obturator (which may be a metal or plastic sharpened or non-bladed tip), a cannula(basically a hollow tube), and a seal. The trocar functions as a portal for the subsequent placement of other instruments, such as graspers, scissors, staplers, etc. It is also intended to remove air or fluid for the pleural space in a closed, one way fashion. 13. Catheters Ureteral stent Indicated to relieve obstructions in C variety of benign, malignant and post- traumatic condition in the ureter. These conditions include stones and/or stone fragments or other Ureteral obstructions such as those associated with ureteral strictures, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma or in association with the Extracoporeal Shock wavelithotripsy (ESWL). The stent may be placed using endoscopic or percutaneously using standard or radiographic technique. 14. Heart Valves Transcatheter Heart It is intended for people with D Valve symptomatic aortic stenosis who are considered an intermediate or high risk patient for standard valve replacement surgery. 15. Surgical Dressings Liquid bandage Prevention of injection by limiting B exposure to dirt and germs in case of minor cuts, abrasions and blisters. 16. Disposable Perfusion Hemoconcentrator set A hemoconcentrator is a fluid removal C Sets device used during cardio bypass surgery. The device is inserted into the extracorpeal circuit where it acts to control hemodilution, maintain hematocrit levels and reduce the need for additional blood products during and after surgery. 17. Disposable Perfusion Apheresis Kit Intended for the collection and C Sets separation of blood components 18. Disposable Perfusion Blood Filter System Intended for collection and preparation C Sets of various blood components 19. Internal Prosthetic Injectable implant for Treatment of vesicoureteral reflux C Replacements the treatment of vesicoureteral reflux 20. Surgical Dressings Bone wax/Haemostat To stop bleeding at bones in C orthopaedics and traumatology, thoracic surgery, dental, oral jaw surgery, neurosurgery. 21. Disposable Hyaluronic acid (cross For intradermal implantation and facial C Hypodermic Syringes linked) Pre-filled soft tissue augmentation. syringe 22. Disposable Crosslinked sodium It is indicated as viscoelastic C Hypodermic Syringes hyaluronate supplement or a replacement for synovial fluid in human joints. It is suited for treatment of symptoms of human joint dysfunctions such as osteoarthritis. The actions of the product are lubrication and mechanical support. 23. Disposable Hyaluronic acid with It is indicated for the treatment of fine C Hypodermic Syringes Lidocaine (cross lines and medium sized skin linked) Pre-filled depressions and correcting infraorbital syringe skin depressions via deep injection24. Disposable Perfusion Heat and moisture It is intended to use for airway B Sets exchange/filter management by anaesthesia/respiratory care department. 25. Catheters Balloon dilators for Used to dilate strictures of the C Gastroenterology gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon. 26. Internal Prosthetic Hernia mesh Indicated to reinforce soft tissue where C Replacements weakness exists, i.e., repair of hernias and chest wall defects. 27. Disposable Dental needles Dental needles are used to deliver local B Hypodermic Needles anaesthetic to the operative site in order to make a patient as comfortable as possible. 28. Disposable Spinal Needles Used for diagnostic sampling of B Hypodermic Needles cerebrospinal fluid, delivering anesthetics and for the introduction of contrast medium 29. Disposable Ophthalmic Viscoelastic solution for Intraocular use C Hypodermic Syringes Viscosurgical Device during eye surgery. 30. Catheters Negative pressure Intended to generate negative pressure C wound therapy or suction to remove wound exudates , bandage infection materials and tissue debris from the wound bed which may promote wound healing. 31. Ablation Devices Needle Electrode The needle electrode family is intended C to be used in conjunction with the RF generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. 32. Ablation Devices Radio Frequency (RF) Intended for general use in C Generator electrosurgical coagulation of tissue. 33. Surgical dressings Absorbent Cotton wool It is intended to used for applying A medication to, or absorbing small amounts of body fluidsNotice File No. 29/Misc/3/2018-DC(85) Date: 06.06.2018 In continuation to the earlier Notice vide File No: 29/Misc./3/2017-DC(292) dated 01.11.2017 regarding Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017, the Annexure-1 is hereby revised for the following changes: 1. Deletion of S.N. 333 i.e. Sterile Drapes. 2. Revision of risk class of following products: S.N. Product Name Earlier Risk Revised Risk Classification Classification 256 Intra Osseous Class B Class C Fixation Wire 259 Bone Wire Class B Class C 260 Bone Cap Class B Class C 321 Plates, Clippers, Class B Class C Screws ***Annexure 1 (Amended as on 06.06.2018) LIST OF MEDICAL DEVICES AND IN VITRO DIAGNOSTICS ALONG WITH THEIR RISK CLASS AS PER THE PROVISIONS OF RULE 4 OF THE MEDICAL DEVICES RULES 2017 (A) List of Medical Devices under provisions of sub-rule (1) rule 4 of the Medical Devices Rules, 2017 Notified Device Risk General # Category/Drug Device Name Intended Use Class It is a non-thermal, minimally-invasive choice for treating the source of Vein Ablation 1. Ablation Device Class C varicose veins, providing patients with Device immediate recovery and a return to normal daily routines Destruction of tissue by application of heat. Ablation of the endometrium as a Thermal Ablation 2. Ablation Device Class C treatment for menorrhagia is performed Device by placing a balloon filled with hot water in the uterine cavity. A medical procedure in which part of the electrical conduction system of the Radiofrequency heart, tumour or other dysfunctional 3. Ablation Device Class D Ablation Device tissue is ablated using the heat generated from high frequency alternating current Clinical applications using hollow Percutaneous needles (cryoprobes) through which 4. Ablation Device Conduction Tissue Class D cooled, thermally conductive, fluids are Ablation circulated. Intended for use in inactivating portions of the heart's conduction system to prevent abnormal heartbeat Suction Ablation 5. Ablation Device Class D rates, comprises a tubular body having Catheter System an open, distal end and a proximal aperture for applying suction through the catheter and through the distal end.System is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in Uterine balloon 6. Ablation Device Class C premenopausal women with therapy devices menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete. RF Conducte MR 7. Ablation Device steerable electrode Class C It is intended for intracardiac ablation. catheter Intended for use in arthroplastic procedures of the hip, knee, and other 8. Bone Cements Bone cement Class C joints for the fixation of polymer or metallic prosthetic implants to living bone. A coronary stent is a tube-shaped device placed in the coronary arteries 9. Cardiac Stents Coronary stent Class D that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease. An absorbable stent which is placed Bioresorbable into a blood vessel (coronary artery) 10. Cardiac Stents Vascular Scaffold Class D during angioplasty to help keep the (BVS) System coronary artery open. Intended for improving the side branch 11. Cardiac Stents Bifurcation Stent Class C luminal diameter of arterial bifurcation liaisons. Intended for monitoring the balance Fiberoptic 12. Catheters Class B between oxygen delivery and Oximeter Catheter consumption at the bedside A blood access device and accessories A-V Shunt or is a device intended to provide access 13. Catheters Class B Fistula Adapter to a patient's blood for haemodialysis or other chronic uses. Transcervical(Ami It is a device designed to permit direct 15. Catheters noscope) Class B viewing of the foetus and amniotic sac Endoscope and by means of an open tube introducedaccessories into the uterus through the cervix. Grasping Forceps device is intended to Forceps, be used to grasp tissue, retrieve foreign 16. Catheters Class B endoscopic bodies, and remove tissue from within the gastrointestinal tract. It is a device designed to permit direct Transabdominal visual examination of the foetus by a (Fetoscope) 17. Catheters Class C telescopic system via abdominal entry. Aminoscope and The device is used to ascertain foetal Accessories abnormalities An anaesthesia conduction kit is a device used to administer to a patient Anaesthetic 18. Catheters Class C conduction, regional, or local Conduction Kit anaesthesia. The device may contain syringes, needles, and drugs. It delivers radio opaque media and Angiographic therapeutic agents to selected sites in 19. Catheters Guide Wire Class D the vascular system. It is also used to lead a guide wire or a catheter into the target site. Cardiac catheterization is a general term for a group of procedures that are Cardiac 20. Catheters Class D performed using this method, such Catherization Kit as coronary angiography and left ventricle angiography Vena Cava Filter Sets Class C It is indicated for the prevention of recurrent pulmonary embolism via 21. Catheters placement in the vena cava to treat various disease conditions. A vessel dilator for percutaneous catheterization is a device which is Vessel Dialator for placed over the guide wire to enlarge 22. Catheters percutaneous Class B the opening in the vessel, and which is Catheterization then removed before sliding the catheter over the guide wire. Clearing the airways of mucus, pus, or Tracheobronchial 23. Catheters Class B aspirated materials to improve oxygena Suction Catheter tion and ventilation. The device is used to avoid postoperative wound and respiratory complications such as excessive 24. Catheters Cervical Drain Class B edema, hematoma, infection, re- intubation, delayed extubation, or respiratory distressReducing the intrafraction motion and improving the sparing of rectal wall by 25. Catheters Rectal Balloon Class B reducing the rectal volume in the high- dose region, resulting in significant reduction in rectal toxicity. Balloon for Balloon used to treat Blockage or 26. Catheters Cerebrovascular Class D closing of Cerebrovascular Occlusion vessels/carotid arteries Intra-Aortic It is a mechanical device that increases 27. Catheters System Balloon Class D myocardial oxygen perfusion while at and Control the same time increasing cardiac output Intend to extract stones in an antegrade fashion through an ampullary orifice Biliary Stone 28. Catheters Class B previously treated by endoscopic Retrieval Basket sphincterotomy or less commonly with balloon dilation Tracheostomy A breathing tube inserted into a 29. Catheters Tube/Tracheal Class B tracheotomyused to obtain a closed Tube circuit for ventilation It is indicated to allow multiple needleless access to injection 30. Catheters Vial Adapter Class B medication vials for transfer or withdrawal of fluids from the vial. an emergency measure for the relief of Suprapubic, non- acute urinary retention or condition 31. Catheters disposable Cannula Class B which require temporary and permanent drainage of bladder. A catheter (for adults) passed through Nasopharyngeal the nares and advanced to the depth of 32. Catheters Catheter/Nasophar Class A the nasopharynx to remove air choke or yngeal obstruction. AResuscitator. Inserted through a patient's mouth to aid ventilation of the patient during Esophageal emergency resuscitation by occluding 33. Catheters Class B obturator (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. An instrument for reattachment of a Balloon Catheter detached retina to the inner wall of the 34. Catheters for Retinal Class B eyeball. It can be inserted into the Reattachment interior of the eyeball. Gastric, Colonic, Used for instilling fluids into, etc.) Irrigation and withdrawing fluids from, splinting, or 35. Catheters Class B Aspiration suppressing bleeding of the alimentary Catheter tract.Suction Catheters feature a whistle tip Suction Tip and 36. Catheters Class B and a thumb control port for precise Catheter and accurate suctioning. Designed to provide a pathway for Angiographic delivering contrast media to selected 37. Catheters Class B Catheter sites in the device vascular system including the carotid arteries. Intended to be used in conjunction with steerable guidewires in order to access 38. Catheters Arterial Catheter Class B discrete regions of the coronary and peripheral arterial vasculature. "Soft" catheter with an inflatable "balloon" at its tip which Balloon Type 39. Catheters Class B is used during a catheterization Catheter procedure to enlarge a narrow opening or passage within the body. Intended for use in Percutaneous Transluminal Angioplasty of the renal, Balloon Dialation 40. Catheters Class B tibial, popliteal, femoral and peroneal Vessel Catheter arteries. These catheters are not for use in coronary arteries. Catheter is used for the treatmenti of Bartholin Gland 41. Catheters Class B abscesses and cysts of the Hartholin Catheter gland. Intended to deliver therapeutic and Bronchography 42. Catheters Class B diagnostic agents that are indicated or Catheter labeled for airway, tracheal or Diagnostic evaluation of the bile ducts Cholangiography 43. Catheters Class B during laparoscopic cholecystectomy Catheter procedures An anesthesia conduction catheter is a Anesthetic flexible tubular device used to inject 44. Catheters Conduction Class B local anesthetics into a patient and to Catheter provide continuous regional anesthesia A microporous filter used while administering to a patient injections of Anesthesia 45. Catheters Class C local anesthetics to minimize conduction filter particulate (foreign material) contamination of the injected fluid Continuous Flush Intended for the controlled and 46. Catheters Class B Catheter selective infusion of Intended to be used to introduce fluids into body cavities other than blood Continous 47. Catheters Class B vessels, drain fluids from body cavities, Irrigation Catheter or evaluate certain physiologic conditions.It is a urinary catheter, It may be used 48. Catheters Coude Catheters Class B to inject liquids used for treatment or diagnosis of bladder conditions. A tubular, flexible instrument, passed t 49. Catheters Depezzer Catheter Class B hrough body channels for withdrawal o f fluids from a body cavity. Intended for vascular access infusion Double lumen and withdrawal of blood, blood Female products, and fluids, plasma pheresis, 50. Catheters Class B Urethrographic hyperalimentation, central venous Catheter blood sampling and continuous and intermittent drag infusion. Epidural catheter is a very thin, flexible 51. Catheters Epidural Catheter Class B tube that is implanted into spine Esophageal intended for use in adult and adolescent 52. Catheters Class B Balloon Catheter populations Eustachian It is used to test Eustachian tube 53. Catheters Class B Catheter patency The guide catheter provides support for 54. Catheters Guiding Catheter Class B device advancement . A catheter used for exchanging blood Haemodialysis 55. Catheters Class B to and from the haemodialysis machine Catheter from the patient. It is indicated for use in patients requiring administration of solutions, Central Venous Class C 56. Catheters blood sampling, central venous Catheters pressure monitoring and injection of contrast media. Intramuscular A modified fibre optic transducer- Pressure tipped catheter system for measuring 57. Catheters Class B Monitoring intramuscular pressures during exercise Catheter was determined. Intended to provide easier access to the 58. Catheters Introducer Sheath Class C femoral, popliteal and infrapopliteal arteries. A catheter that is inserted into a vein fo r supplying medications or nutrients dir Intravenous 59. Catheters Class B ectly into the bloodstream or for diagno Catheter sticpurposes such as studying blood pre ssure Jejunostomy Used for intraoperative feeding 60. Catheters Class B Catheter jejunostomy Intended for monitoring central venous Multiple Lumen 61. Catheters Class B pressure (CVP), sampling blood, and Cathetersimultaneous administration ofmultiple IV solutions or drugs. It is a device used to Nasal Oxygen deliver supplemental oxygen or 62. Catheters Class B Catheter increased airflow to a patient or person in need of respiratory help. It is indicated for general use as a guidewire and embolic protection system Embolic Filter Class D during angioplasty and stenting 63. Catheters system procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm. Used while performing angioplasty and 64. Catheters Carotid Filter System Class C stenting procedures in carotid arteries. intended for use in the retrieval and manipulation of atraumatic foreign bodies 65. Catheters RETRIEVAL SNARE Class C located in the coronary and peripheral cardiovascular system and the extra- cranial neurovascular anatomy. intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral system RETRIEVAL and the extra cranial 66 Catheters SNARE Class D neurovascular anatomy. A nephrostomy is a tube that’s used to Nephrostomy 67. Catheters Class B drain urine from a kidney into a bag Catheter outside the body. That allows dialysis fluid to enter the Peritoneal Dialysis 68. Catheters Class B abdominal cavity, dwell inside for a Catheter while, and then drain back out again Interventional radiologists obtain images using needles and narrow tubes Radiographic (Non 69. Catheters Class B called catheters, rather than by making Vascular) Catheter large incisions into the body as in traditional surgery. It is inserted into the rectum in order to relieve flatulence which has been 70. Catheters Rectal Catheter Class B chronic and which has not been alleviated by other methods. This type of catheter is placed into the Retention Type 71. Catheters Class B bladder and secured there for a period Catheter of time. It has a balloon at the distal end, which 72. Catheters Retention Type Class B is inflated with sterile water or saline toBalloon Catheter prevent the catheter from slipping out of the bladder Salpngography Used for injection of contrast medium 73. Catheters Class B Catheter into the fallopian tube(s) for selectivesalpingography. Single Needle The single-needle dialysis, in which Hemodialysis case only one cannula or a single- 74. Catheters Class B Catheter/Blood lumen catheter is used to access the lines blood It is used in patients with neurogenic 75. Catheters Straight Catheter Class B bladder or spinal cord injury, lessens the risk of urinary tract infection Catheters can be placed in veins in the Subclavian 76. Catheters Class B neck (internal jugular vein), chest Catheter (subclavian vein or auxiliary vein), Suprapubic A suprapubic catheter is a thin, sterile 77. Catheters Class B Catheter tube used to drain urine from bladder. Umbilical artery catheterization provides direct access to the arterial blood supply and allows accurate Umblical Artery 78. Catheters Class B measurement of arterial blood pressure, Catheter a source of arterial blood sampling, and intravascular access for fluids and medications Upper Urinary The catheter to the bladder and 79. Catheters Class B Tract Catheter subsequently to the upper urinary tract Urethral A long, small gauge catheter designed f Catheter/Nelaton or insertion directly into a ureter, either 80. Catheters Class B Catheter/ Foley through the urethra andbladder or post Catheter eriorly via the kidney. Urethrographic A catheter 81. Catheters Class B Male Catheter used to pass into a man's bladder. An ultrasound guides a thin Chorionic Villus catheter through the cervix to your 82. Catheters Class B Sampling Catheter placenta. The chorionic villi cells are gently suctioned into the catheter. Sclerotherapy Needles are designed to provide access for injection therapy Sclerotherapy 83. Catheters Class B applications and may also be used for Needle/ Catheter polypectomy and endoscopic mucosal resection (EMR) A device used to dislodge stones from Water Jet Renal renal calyces (recesses of the pelvis of 84. Catheters Class B Catheter the kidney) by means of a pressurized stream of water through a conduit.A dialysis catheter is a catheter used Hemodialysis for exchanging blood to and from 85. Catheters Catheter (Long Class C the hemodialysis machine from the Term ) patient. The dialysis catheter contains two lumens: Venous. Arterial The device allows for repeated access to the vascular system for long-term Percuataneous use of 30 days or more, and it is 86. Catheters Intravascular Long Class C intended for administration of fluids, Term Catheter medications, and nutrients; the sampling of blood; Percutaneous Long To conduct a preimplantintra spinal 87. Catheters Term Intraspinal Class C infusion screening trial procedure prior Catheter to implanting a pump Implanted The device allows for repeated access Subcutaneous to the vascular system for the infusion 88. Catheters Class C Intravascular Port of fluids and medications and the & Catheter sampling of blood Catheters used for both epidural Subcutaneous Intrathecal infusion include short-term 89. Catheters Intraspinal Port & Class C externalized catheters and long-term Catheter catheters that are tunnelled in the subcutaneous tissue Peripheral, Transluminal A catheter for 90. Catheters Class C Angioplasty treating peripheral vascular diseases Catheter A catheter used in thermodilution for in troduction of the cold liquid indicator i nto thecardiovascular system or for the Cardiac assessment of a patient’s hemodynamic 91. Catheters Thermodilution Class D condition through simultaneous right Catheter atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions. A thin, hollow tube called a catheter is Cardiovascular 92. Catheters Class D inserted into a large blood vessel that Catheter leads to heart. For treatment or prevention of Cerebrospinal 93. Catheters Class D cranial/spinal cerebrospinal fluid Catheter fistula. A catheter containing a rotating cutter Atherectomy 94. Catheters Class D and a collecting chamber for debris, Coronary Catheter used for atherectomy andendarterectomy. Electrode A cardiac catheter containing one or Recording Probe, more electrodes; it may be used to pace 95. Catheters Class D Electrode the heart or to deliver high energy Recording Catheter shocks. It is indicated for the assessment of a patient’s hemodynamic condition through Oximetry direct intracardiac and pulmonary artery catheters, 96. Catheters Class B pressure monitoring, cardiac output Oximetry Paceport determination, continuous mixed venous catheter oxygen saturation monitoring, and for infusing solutions Embolectomy indicated for the removal of fresh, soft 97. Catheters Class D Catheter emboli and Flow Directed Used for venous sampling and 98. Catheters Class B Catheter pressure monitoring. Ultrasonic maging intended for ultrasound examination of 99. Catheters Class B Catheter peripheral pathology only Intraaortic Balloon It is indicated for use in patients 100. Catheters Class D Catheter undergoing cardiopulmonary bypass. A high density array catheter once used Intracardiac in the right atrium to map and Mapping, High 101. Catheters Class D diagnosis Density Array complexarrhythmias and assess the effe Catheter ctiveness of ablation treatment. It is intended for balloon dilatation of a hemodynamically significant coronary Coronary Dilation artery or bypass graft stenosis in 102. Catheters Class C Catheter patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. It is a catheter with an inflatable or detachable balloon tip that is used to Intravascular 103. Catheters Class D block a blood vessel to treat Occluding Catheter malformations, e.g., aneurysms of intracranial blood vessels Intravascular Used to record intracardiac pressures, 104. Catheters Diagnostic Class D to sample blood, and to introduce Catheter substances into the heart and vessels. Insertion of a device or develop at any 105. Catheters Occlusion Catheter Class D time during the course of intravenous (IV) therapy.A needle catheter getting access to a Percutaneous blood vessel, followed by the 106. Catheters Class D Catheter introduction of a wire through the lumen (pathway) of the needle. Angiography catheters are designed to be used for delivering radiopaque Diagnostic Radiology 107. Catheters Class C media to selected sites in the vascular Catheters system in conjunction with routine diagnostic procedures. Perfusion catheter allowing localised perfusion of drugs not only into the 108. Catheters Perfusion Catheter Class D vessel lumen, but also directly into the vessel wall at low pressure, during coronary intervention. - Pericardium 109. Catheters Class D Catheter drainage of the pericardium Drainage Catheter Atherectomy Intended for use in atherectomy of the 110. Catheters Class D Peripheral Catheter peripheral vasculature. Septostomy 111. Catheters Class D Used to enlarge interatrial openings Catheter Thrombectomy catheter is specifically Thrombectomy designed to treat deep vein thrombosis 112. Catheters Class D Catheter (DVT) in large-diameter upper and lower peripheral veins. Transluminal, Coronary The catheter is placed in the opening or 113. Catheters Angioplasty, Class D ostium of one the coronary arteries Percutaneous Catheter It is used to monitor pressure in Ventrricular patients with brain injuries, intracranial 114. Catheters Class C Catheter bleeds or other brain abnormalities that lead to increased fluid build-up. A device used to repair or replace the balloon of a balloon catheter. The kit Balloon Repair Kit 115. Catheters Class C contains the materials, such as glue and Catheter balloons, necessary to affect the repair or replacement.It is intended to access the peripheral and neurovasculature for the controlled selective infusion of physician- 116. Catheters Micro-catheter Class C specified therapeutic agents such as embolization materials and or diagnostic materials such as contrast media Intended for use with the various 117. Catheters Imaging Catheter Class C medical imaging consoles. It is a device or combination of devices Central Nervous used to divert fluid from the brain or System Shunt other part of the central nervous system including 118. Catheters Class D to an internal delivery site or an Neurological external receptacle for the purpose of catheters and other relieving elevated intracranial pressure Components or fluid volume. It is used for proximal and distal Endoscopic 119. Catheters Class B ligation of vessels during endoscopic Ligation Devices vessel harvesting procedures. A tubing connector adapted for Dialysate Tubing peritoneal dialysis connections 120. Catheters Class B and Connector between tubing sets and containers of dialysate A closed urinary drainage system Urinary Drainage consists of a catheter inserted into the 121. Catheters Class B Unit urinary bladder and connected via tubing to a drainage bag It is a small tube inserted into the eardrum in order to keep the middle Tympanostomy 122. Catheters Class C ear aerated for a prolonged period of Tube time, and to prevent the accumulation of fluid in the middle ear In-Vitro A cellular transfer catheter is provided Fertilization/ 123. Catheters Class B for implantation of cellular material Embryo Transfer into the uterus of a patient CatheterIt is designed to provide access for Sclerotherapy injection therapy applications and may 124. Catheters Class B Needle/ Catheter also be used for polypectomy and endoscopic Fluid Delivery 125. Catheters Class B Tube used to deliver fluid in body tubing Colon Tubes also called "Tips" or even Catheters are inserted from the anus, 126. Catheters Colon Tube Class B through the rectum to deliver your enema solution into the colon (large intestine). Used to provide connection to a 127. Catheters Connecting Tube Class B drainage bag. Decompression using a rectal tube may Decompression 128. Catheters Class B assist in the treatment only if the Tube sigmoid colon is involved. Tracheal intubation, usually simply Double Lumen for referred to as intubation, is the intestinal placement of a flexible plastic tube into 129. Catheters Decompression Class B the trachea (windpipe) to maintain an and/or Intubation open airway or to serve as a conduit Tube through which to administer certain drugs. A surgical drain is a tube used to Closed remove pus, blood or other fluids from Wound Drainage 130. Catheters Class B a wound. They are commonly placed Tube or System by surgeons or interventional radiologists. It is a medical device inserted through the nose or mouth and used Oesophageal 131. Catheters Class B occasionally in the management of Blakemore Tube upper gastrointestinal hemorrhage due to oesophageal varices . It is used only in emergencies where Oesophageal bleeding from presumed varices is 132. Catheters Class B Sengtaken Tube impossible to control with medication alone A feeding tube is a device that's inserted into your stomach through 133. Catheters Feeding Tube Class B your abdomen. It's used to supply nutrition when you have trouble eatingTube is placed through the abdominal Gastro- 134. Catheters Class B wall into the stomach and then through Enterostomy Tube the duodenum into the jejunum. A gastrostomy tube (also called a G- Gastrointestinal tube) is a tube inserted through the 135. Catheters Class B Tube abdomen that delivers nutrition directly to the stomach Heart-Lung Bypass A tube will be placed in your heart to 136. Catheters Class B Unit Tube drain blood to the machine. Used for the aspiration of gastric and 137. Catheters Levine Tube Class B intestinal contents and administration of tube feedings or medications. It is a special tube that carries food and NasoGastric Tube/ medicine to the stomach through the 138. Catheters Class B Ryles Tube nose. It can be used for all feedings or for giving a person extra calories. The nephrostomy tube drains urine 139. Catheters Nephrostomy Tube Class B from kidney into a collecting bag outside the body. An orthodontic small metal part welded on the outside of a molar bank, which 140. Catheters Orthodontic Tube Class B contains slots to holdarchwires, lip bu mpers, facebows and other devices use d to move the teeth. A rectal tube, also called a rectal catheter, is a long slender tube which is 141. Catheters Rectal Tube Class B inserted into the rectum in order to relieve flatulence . Passage of a tube via the mouth or nose Stomach down into the stomach followed by 142. Catheters Evaculator(Gastric Class B sequential administration and removal Lavage) Tube of small volumes of liquid. Tonsil Suction 143. Catheters Class B Used to suck out stones in tonsils. Tube Tracheal Inserts the tube with the help of a (Endotracheal) laryngoscope, an instrument that 144. Catheters Class B Tube permits to see the upper portion of the trachea, just below the vocal cords. It is intended for endotracheal suctioning to provide a patient airway Closed Suction 145. Catheters Class B by removing excess fluids, secretions, System exudates and transudate through the artificial airway.It is anchored to mucosa and submucosa 3 centimetres proximal to a Anastomosis 146. Catheters Class C site of colocolonic anastomosis and Bypass Tube later spontaneously evacuated by way of the rectum. During a surgical procedure in which Endolymphatic it is placed in the membranous 147. Catheters Class B Shunt Tube labyrinth of the inner ear to drain excess fluid. A wire conforming to the alveolar or Orthodontic Guide dental arch that can be used with dental 148. Catheters Class B Wire braces as a source of force in correcting irregularities in the position of the teeth It is a medical device which is placed Intra-aortic balloon in the aorta to improve cardiovascular 149. Catheters Class D and control system functioningduringcertain life- threatening emergencies. A ventricular bypass (assistive) device Ventricular bypass is a device that assists the left or right 150. Catheters Class D (assistive) ventricle in maintaining circulatory blood flow. It is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary Catheter Guide 151. Catheters Class D angioplasty (PTCA) and percutaneous Wire transluminal angioplasty (PTA). The PTCA Guide Wires are not to be used in the cerebral blood vessel It is intended to facilitate the placement of balloon ilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and 152 Catheters Catheter Guide Class D percutaneous transluminal angioplasty (PTA). PTCA Guide Wires are not to be used in the cerebral blood vessel. Catheters An esophageal stent is a stent (tube) placed Wire in the oesophagus to keep a blocked area 153. Class C open so the patient can swallow soft food and liquids Catheters Biliary stents provide bile drainage from the gallbladder, pancreas and bile ducts toBiliary stents Class C the duodenum in conditions such 154. as ascending cholangitis due to obstructing gallstonesCatheters Duodenal Stent is indicated for the 155. Duodenal stents Class C palliative treatment of gastroduodenal obstructions Catheters A colonic stent is a flexible, hollow tube designed to keep a segment of the colon (large bowel) open when it has Colonic stent Class C become blocked(obstructed). This 156. blockage is commonly caused by a tumour inside the bowel or by outside pressure on the bowel wall. Catheters Pancreatic duct stents are often placed in Pancreatic stent Class C 157. patients who have chronic pancreatitis Catheters Indicated for the treatment of patients at high risk for adverse events from carotid 158. Carotid Stent System Class D endarterectomy who require carotid revascularization. Catheters A Peripheral stent is a tube-shaped device Peripheral Stent Class C placed in the peripheralarteries that supply 159. System blood into body organ. Tubal Rings/ Contraception devices for female 160. Contraceptives Class C Fallopian Rings sterilization Condom with nonoxynol-9, micro- condom, prophylactic (condom) – latex Male / Female 161. Contraceptives Class C sheath, non-latex, condoms with Condoms natural membrane, intra vaginal condoms etc. Indicated for intrauterine contraception 162. Contraceptives Cu-T Class D for up to 10 years. An agent that destroys pathogenic and other kinds of microorganisms by chemical or physical means. A disinfectant destroys most recognized 163. Disinfectants Disinfectants Class B pathogenic microorganisms, but not necessarily all microbial forms, such as bacterial spores. It is intended to disinfect a medical device. Disposable Used for either laparoscopic aspiration 164. Hypodermic Aspiration Needle Class B or injection NeedlesA thin needle is inserted into an area of abnormal-appearing tissue or body Disposable Aspiration and fluid. As with other types of biopsies, 165. Hypodermic Class B Injection Needle the sample collected during fine needle Needles aspiration can help make a diagnosis or rule out conditions such as cancer. Disposable Insulin Used to inject insulin for the treatment 166. Hypodermic Needles/Pen Class B of diabetes. Needles Needles for insulin Disposable Medication A subcutaneous injection is a method 167. Hypodermic Class B Injector of administering medication. Needles A set of neurosurgical instruments Disposable designed to allow multiple biopsies 168. Hypodermic Biopsy Needle Kit Class B from one or more targets in one Needles trajectory Angiographic needle has a unique hub Disposable Angiographic design with an ergonomic feel and a 169. Hypodermic Class B Needle black triangle indicator to orient the Needles bevel. Disposable The growth sample is suctioned out Mammary Biopsy 170. Hypodermic Class B through a needle or cut out using a Needle Needles surgical procedure Disposable Intended to be used with evacuated blood collection tube for collection of Class B Blood Collecting venous blood. 171. Hypodermic Needle Needles Disposable Bone Marrow Needle inserted in Bone Marrow to 172. Hypodermic Class B Needle collect sample Needles Disposable Gynaecological It is a loop like instrument used to 173. Hypodermic Class B Cerclage Needle suture the cervix. Needles The aspirating needle is passed through Disposable Cholangiography the patient's skin and liver tissue until 174. Hypodermic Class B Needle the tippenetrates one of the hepatic Needles ducts An anaesthesia conduction needle is a Disposable Anaesthetic device used to inject local anaesthetics 175. Hypodermic Class B Conduction Needle into a patient to provide regional Needles anaesthesia Emergency airway puncture is the Disposable Emergency Airway placement of a hollow needle through 176. Hypodermic Class B Needle the throat into the airway. It is done to Needles treat life-threatening choking.Used to sample targeted submucosal Disposable gastrointestinal lesions through the 177. Hypodermic Endoscopic Needle Class B accessory channel of an ultrasound Needles endoscope. Disposable To connect blood lines with the blood 178. Hypodermic Fistula Needle Class B vessels through needles when dialysis Needles is carried out Intended for transient delivery of Disposable anasthetics to provide regional 179. Hypodermic Epidural Needle Class B anesthesia or to facilitate placement of Needles an epidural catheter Disposable Gastro-Urology 180. Hypodermic Class B Intended f o r ga str oe ntero logy b iopsy Needle Needles A hypodermic single lumen needle is a Disposable Single Lumen device intended to inject fluids into, or 181. Hypodermic Hypodermic Class B withdraw fluids from, parts of the body Needles Needle below the surface of the skin. Disposable A needle used in suturing during Neurosurgical 182. Hypodermic Class B neurosurgical procedures or in the Suture Needle Needles repair of nervous tissue. Disposable Mission to collect the maximum Oocyte Aspiration 183. Hypodermic Class B amount of undamaged oocytes in a Needle Needles short time as possible. Disposable Inserting a Veress needle through the Pneumoperitoneu 184. Hypodermic Class B abdominal wall inside the peritoneal m Simple Needle Needles cavity. Disposable Intended for the automatic self- Prefillable Glass 185. Hypodermic Class B administra t io n o f d ru gs and bio lo gics fr om Barrel with needle Needles standard Glass Barrel. A syringe actuator for an injector is an electrical device that controls the Disposable Injector Type timing of an injection by an 186. Hypodermic Class C actuator syringe angiographic or indicator injector and Syringes synchronizes the injection with the electrocardiograph signal. Disposable Used for either laparoscopic aspiration 187. Hypodermic Aspiration Syringe Class B or injection Syringes Disposable cleaning d e bris aw a y from th e area t he 188. Hypodermic Irrigating Syringes Class B dentist is working on SyringesDisposable Used to inject insulin for the treatment 189. Hypodermic Insulin Syringes Class B of diabetes. Syringes Disposable Auto Disable Hypodermic Intend to inject fluids into or withdraw Syringe for Class B 190. Syringes fluids from the body. single use Disposable Traditional single Class B Hypodermic use syringe without safety feature Intend to inject fluids into or withdraw 191. Syringes (Sterile hypodermic fluids from the body. syringes for single use) Disposable Auto-disable (AD) Class B 192. Hypodermic syringes for Intend to inject fluids into or withdraw Syringes immunization fluids from the body. Disposable Re use Prevention Class B Hypodermic (RUP) syringes for therapeutic 193. Syringes injections ( Syrin ges Intend to inject fluids into or withdraw with re-use fluids from the body. prevention feature) Disposable Sharps Injury Class B Hypodermic Protection (SIP) - Intend to inject fluids into or withdraw Plastic needle shield 194. Syringes fluids from the body. to be added to a syringe Sharps Injury Class B It is used to administer blood from a Disposable Blood Class B container to a patient's vascular system 195. Perfusion Sets Administration kits through a needle or catheter insertedinto a vein It is intended for use in the administration of fluids from a Disposable Measured Volume Class B container into the patient's vascular 196. Perfusion Sets IV Set system through a vascular access device. Transfusion Set is used to administer Transfusion or Disposable blood/drugs to a patient's vascular Perfusion sets for Class B 197. Perfusion Sets system through a needle or catheter single use inserted into a vein. Indicated for use in the extra corporeal Disposable Custom Perfusion Class C circuit during cardio pulmonary bypass 198. Perfusion Sets System surgery procedure. Indicated for fluid flow directional Disposable control and for providing access Manifolds Class B 199. Perfusion Sets port/ports for administration of a solution. 3 way stop cock as Class B It is indicated for fluid flow an accessory to directional control and for providing Disposable perfusion sets access port for administration of 200. Perfusion Sets solution, withdrawal of fluid and pressure monitoring Y-Connector as an Class A It can be used to connect to a Disposable accessory to perfusion sets or catheter for 201. Perfusion Sets perfusion sets infusion of contr ast media etc. I V Flow regulator Class B An IV system and administration Disposable device offering precision care and 202. Perfusion Sets consistent delivery. Extension Sets Class B Extension sets are sterile devices for single use only. They are intended to be Disposable used as part of a system for the infusion 203. Perfusion Sets of fluids/medications in medical applications. The Infusion Pumps intended for slow, continuous delivery through clinically acceptable routes of administration Infusion Pump or such as intravenous (IV), intra-arterial Disposable Elastomeric Class C 204. Perfusion Sets Infusion De vice (IA), and subcutaneous or epidural infusion of medications directly into an intra-operative site or subcutaneously for post operative pain management.Stent, coronary, drug-eluting - a metal scaffold with a drug coating placed via Drug Eluting a delivery catheter into the coronary Drug eluting stent Class D 205. Stents artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis. A device intended to perform the 206. Heart Valves Heart valve Class D function of any of the heart's natural valves. Intended to be used in breast reconstruction or treatment of soft Internal Prosthetic Tissue Expanders Class C tissue deformities such as used 207. Replacements following mastectomy or for treatment of underdeveloped breasts. Internal Prosthetic Intended for reconstruction and repair Bio Patches Class C 208. Replacements of defects of pericardium. Intended to repair, replace, or bypass Vascular sections of native or artificial vessels, Internal Prosthetic graft/occluders/Car Class D excluding coronary or cerebral 209. Replacements diac Patches vasculature, and to provide vascular access. Vascular It is an intravascular implant intended Internal Prosthetic embolization Class D to control hemorrhaging due to 210. Replacements device aneurysms, certain types of tumors. The device is intended to direct pulmonary Internal Prosthetic Voice / laryngeal air flow to the pharynx in the absence of Class C 211. Replacements Prothesis the larynx, for permitting esophageal speech. An intra-cardiac patch or pledgete which is a medical device placed in the Internal Prosthetic Cardiovascular Class D heart and is used to repair septal 212. Replacements prosthetic devices defects, for patch grafting, to repair tissue, and to buttress sutures.The prostheses are intended for partial Internal Prosthetic Hearing Prosthesis Class C ossicular replacement to restore 213. Replacements System functionality to the middle ear . An annuloplasty ring implanted around Internal Prosthetic Annuloplasty ring Class C the mitral or tricuspid heart valve for 214. Replacements reconstructive treatment. It is a device intended to be implanted for the functional reconstruction of Total ossicular Internal Prosthetic segments of the ossicular chain and replacement Class D 215. Replacements faci litates the cond ucti on of sound prosthesis wave from the tympanic membrane to the inner ear. It is a device material that is intended Ear, nose, and to be implanted for use as a space- Internal Prosthetic throat and facial Class C occupying substance in the 216. Replacements synthetic polymer reconstructive surgery of the head and material or implant neck. Mandibular Intended to be implanted for use in the Internal Prosthetic implant facial Class C functional reconstruction of mandibular 217. Replacements prosthesis deficits. Internal Prosthetic Sacculotomy tack Intended to be implanted to relieve the Class C 218. Replacements (Cody tack) symptoms of vertigo. Internal Prosthetic Endolymphatic Intended to be implanted to relieve the Class C 219. Replacements shunt symptoms of vertigo. It is a device that consists of a An endolymphatic pressure-limiting valv e associated with Internal Prosthetic shunt tube with Class C a tube intended to be implanted in the 220. Replacements valve inner ear to relieve symptoms of vertigo and hearing loss. A device designed to maintain the Internal Prosthetic Fallopian tube patency (openness) of the fallopian Class C 221. Replacements prosthesis tub e and is used after rec onst ruct ive surgery. A device used to enlarge the vagina by Internal Prosthetic stretching, or to support the vagina and Vaginal stent Class C 222. Replacements to hold a skin graft after reconstructive surgery. An eye sphere implant is a device intended to be implanted in the eyeball Internal Prosthetic Eye sphere implant Class D to occupy space following the removal 223. Replacements of the contents of the eyeball with the sclera left intact.It is a device intended to provide a transparent optical pathway through an Internal Prosthetic Keratoprosthesis Class D opacified cornea, either 224. Replacements intraoperatively or permanently, in an eye. Intended to be implanted that is made Internal Prosthetic from bovine bones and used to replace Bone heterograft Class D 225. Replacements human bone following surgery in the cervical region of the spinal column. Intended to be implanted into the Internal Prosthetic Intramedullary Class C medullary (bone marrow) canal of long 226. Replacements fixation rod bones for the fixation of fractures. Intended to be surgically placed in the Internal Prosthetic Endosseous dental bone of jaw arches to provide support Class C 227. Replacements implant for prosthetic devices, such as artificial teeth. A dental implant is a surgical component that interfaces with the bone of the jaw or skull to support Internal Prosthetic Dental implant Class C a dental prosthesis such 228. Replacements as crown, bridge, denture, facial prosthesis or to act as an orthodontic anchor. Intended to fill, augment, or reconstruct Internal Prosthetic Bone grafting Class C periodontal or bony defects of the oral 229. Replacements material and maxillofacial region. Intended to be implanted in the human Total jaw to replace the mandibular condyle Internal Prosthetic temporomandibula Class D and augment the glenoid fossa to 230. Replacements r joint prosthesis functionally reconstruct the temporomandibular joint. Intended to be implanted in the temporomandibular joint to augment a Internal Prosthetic Glenoid fossa Class D glenoid fossa or to provide an 231. Replacements prosthesis articulation surface for the head of a mandibular condyle. Intended to be implanted in the human Internal Prosthetic Mandibular Class D jaw to replace the mandibular condyle 232. Replacements condyle prosthesis and to articulate within a glenoid fossa. Intended to be an interface between the Internal Prosthetic An interarticular Class D natural articulating surface of the 233. Replacements disc prosthesis mandibular condyle and glenoid fossa.A penile inflatable implant is a device which is implanted in the penis, connected to a reservoir filled with Internal Prosthetic Penile inflatable radiopaque fluid implanted in the Class D 234. Replacements implant abdomen, and a subcutaneous manual pump implanted in the scrotum. This device is used in the treatment of erectile impotence. A device that is implanted in the corpora cavernosa of the penis to Internal Prosthetic Penile rigidity Class C provide rigidity. It is intended to be 235. Replacements implant used in men diagnosed as having erectile dysfunction Artificial Urinary Internal Prosthetic It is used to prevent incontinence by Sphincters Class C 236. Replacements occluding the urethra. implants An implanted mechanical/hydraulic Implanted urinary continence device is a device Internal Prosthetic mechanical/hydrau used to treat urinary incontinence by Class C 237. Replacements lic urinary the application of continuous or continence device intermittent pressure to occlude the urethra. A cochlear implant is an implanted electronic hearing device, designed to Internal Prosthetic produce useful hearing sensations to a Cochlear implant Class D 238. Replacements perso n w ith sev ere t o profoun d nerve deafness by electrically stimulating nerves inside the inner ear. The retinal implant is meant to partially Internal Prosthetic restore useful vision to people who Retinal implant Class D 239. Replacements have lost their vision due to degenerative eye conditions Internal Prosthetic Breast implant is used to increase the Breast implant Class C 240. Replacements breas t siz e. It is intended to be implanted to restore Internal Prosthetic Tracheal prosthesis Class C the structure and/or function of the 241. Replacements trachea or trachealbronchial tree The polymeric mesh comprises an absorbable polymeric fibre and a non- Internal Prosthetic Polymeric Surgical Class C absorbable polymeric fibre knitted together 242. Replacements Mesh to form an interdependent, co-knit mesh structure. Internal Prosthetic Endosseous dental Class C Intended for use as an aid in prosthetic 243. Replacements implant abutment rehabilitation.A testicular prosthesis is an implanted A testicular device that consists of a solid or gel-filled Internal Prosthetic Class D 244. Replacements prosthesis silicone rubber prosthesis that is implanted surgically to resemble a testicle. It is intended for the endovascular Aneurysm Implant embolization of intracranial aneurysms Internal Prosthetic (detachable Class D and other neurovascular abnormalities Replacements coils/clips) such as arteriovenous malformations and arteriovenous fistulae. Intraocular lens (IOL) Intra Ocular Intraocular lens Class C are lens implanted in the eye used to 246. Lenses treat cataracts or myopia The IV Cannula is a passive device to provide for the infusion of fluids, Intravenous 247. IV Cannulae Class B drugs, and/or blood components, or to Cannula facilitate the placement of Vascular Access devices . Inserted into an artery, commonly the radial artery, and is used during major 248. IV Cannulae Arterial Cannula Class B operations and in critical care areas to measure beat-to-beat blood pressure and to draw repeated blood samples. Coronary Artery Cannulation technique for left-sided 249. IV Cannulae Class B Cannula coronary artery surgery. Allowing the arterial blood to flow to the dialyzer and the dialyzed blood to Hemodialysis 250. IV Cannulae Class B return from the dialyzer to the Cannula circulation through the cannula in the vein. Vena Cava Inserted into Vena Cava, taking 251. IV Cannulae Class B Cannula deoxygenated blood to heart. It is intended for use as a single cannula for both venous drainage and 252. IV Cannulae Venous Cannula Class B reinfusion of blood via an internal jugular vein during extracorporeal life support procedures. For use in neurosurgical procedures. It Ventricular is specially designed to penetrate 253. IV Cannulae Class B Cannula delicate brain tissue and give continued access to brain’s ventricular system. It is inserted into one of the client's A-V Shunt 254. IV Cannulae Class C blood vessels to facilitator repeated Cannula hemodialysis.A lymph duct is a great lymphatic Cannulact or 255. IV Cannulae Class B vessel that empties lymph into one of Lymph Duct the subclavian veins Stabilization of fractured bony parts by Orthopaedic Intra Osseous Class C direct fixation to one another with 256. Implants Fixation Wire surgical wires Cortical Fixation Cortical Fixation System is a machined Orthopaedic Implant / rigidloop titanium implant designed to provide Class C 257. Implants Adjustable Cortical fixation in the repair of tendons and Fixation System ligaments. Intervertebral Body It is indicated for use with autogenous Orthopaedic Fusion Class C bone graft in skeletally mature patients 258. Implants Device / Fuse Spinal with degenerative disc disease ("DDD") at System one or two contiguous spinal levels. Orthopaedic Bone Wire Class C Intended to be used for bone stabilization 259. Implants in the hand and wrist. Orthopaedic Intended to be implanted to cover the Bone cap Class C 260. Implants end of a bone. Orthopaedic Orthopedic implant Intended to replace a missing joint or Class C 261. Implants & accessories bone or to support a damaged bone. The device is inserted into the Orthopaedic Intervertebral body intervertebral body space of the Class D 262. Implants fusion devic e cervical or lu mbo sa cra l s pine, and is intended for intervertebral body fusion It is used to intended to provide Orthopaedic Pedicle screw Class C immobilization and stabilization of 263. Implants spinal system spinal segments Ankle joint An ankle joint metal/composite semi- metal/composite Orthopaedic constrai ned c eme nte d pro sthesi s is a semi-constrained Class C 264. Implants device inten ded to be impla nted to cemented replace an ankle joint. prosthesis Ankle joint A device intended to be implanted to metal/polymer replace an ankle joint. The device Orthopaedic non-constrained Class C limits minimally translation in one or 265. Implants cemented more planes. It has no linkage across- prosthesis the-joint. Elbow joint An elbow joint metal/polymer metal/polymer Orthopaedic constrained cemented prosthesis is a constrained Class C 266. Implants device intended to be implanted to cemented replace an elbow joint. prosthesisElbow joint An elbow joint metal/polymer semi- metal/polymer Orthopaedic constrained cemented prosthesis is a semi-constrained Class C 267. Implants device intended to be implanted to cemented replace an elbow joint prosthesis An elbow joint radial (hemi-elbow) elbow joint radial polymer prosthesis is a device intended Orthopaedic (hemi-elbow) Class C to be implanted made of medical grade 268. Implants polymer silicone elastomer used to replace the proximal end of the radius. A device intended to be implanted Elbow joint made of alloys, such as cobalt- humeral (hemi- Orthopaedic chromium-molybdenum, that is used to elbow) metallic Class C 269. Implants replace the distal end of the humerus uncemented formed by the trochlea humeri and the prosthesis capitulumhumeri A device intended to be implanted elbow joint made of alloys, such as cobalt- humeral (hemi- Orthopaedic chromium-molybdenum, that is used to elbow) metallic Class C 270. Implants replace the distal end of the humerus uncemented formed by the trochlea humeri and the prosthesis capitulumhumeri Finger joint metal/metal A device intended to be implanted to Orthopaedic constrained Class C replace a metacarpophalangeal or 271. Implants uncemented proximal interphalangeal (finger) joint prosthesis Finger joint A finger joint metal/metal constrained metal/metal Orthopaedic cemented prosthesis is a device constrained Class C 272. Implants intended to be implanted to replace a cemented metacarpophalangeal (finger) joint prosthesis Finger joint A device intended to be implanted to Orthopaedic polymer Class C replace a metacarpophalangeal or 273. Implants constrained proximal interphalangeal (finger) joint prosthesis hip joint metal A hip joint metal constrained cemented constrained Orthopaedic or uncemented prosthesis is a device cemented or Class D 274. Implants intended to be implanted to replace a uncemented hip joint prosthesis Hip joint A hip joint metal/polymer constrained metal/polymer Orthopaedic cemente d or uncem ented pro sth esis is a constrained Class D 275. Implants device intended to be implanted to cemented or replace a hip joint uncementedprosthesis Hip joint metal/metal semi- constrained, with a Orthopaedic It is a prosthesis intended to be cemented Class D 276. Implants implanted to replace a hip joint acetabular component, prosthesis. hip joint metal/metal semi- constrained, with Orthopaedic Intended to be implanted to replace a an uncemented Class D 277. Implants hip joint acetabular component, prosthesis hip joint A hip joint metal/composite semi- metal/composite Orthopaedic constrained cemented prosthesis is a semi-constrained Class C 278. Implants two-part device intended to be cemented implanted to replace a hip joint prosthesis Hip joint metal/ceramic/poly mer semi- Orthopaedic constrained Intended to be implanted to replace a Class C 279. Implants cemented or hip joint nonporous uncemented prosthesis Hip joint metal/polymer/met Orthopaedic al semi-constrained Intended to be implanted to replace a Class C 280. Implants porous-coated hip joint uncemented prosthesis. A knee joint femorotibial metallic constrained Orthopaedic Intended to be implanted to replace cemented Class C 281. Implants part of a knee joint prosthesis is a device intended to be implanted to replace part of aknee joint Shoulder joint metal/metal or Orthopaedic metal/polymer Intended to be implanted to replace a Class C 282. Implants constrained shoulder joint cemented prosthesis Wrist joint carpal Orthopaedic Intended to be implanted to replace the lunate polymer Class C 283. Implants carpal lunate bone of the wrist. prosthesis Wrist joint metal/polymer Orthopaedic Intended to be implanted to replace a semi-constrained Class C 284. Implants wrist joint. cemented prosthesis Wrist joint metal Orthopaedic constrained Intended to be implanted to replace a Class C 285. Implants cemented wrist joint prosthesis Wrist joint Orthopaedic polymer Intended to be implanted to replace a Class C 286. Implants constrained wrist joint prosthesis Wrist joint carpal Orthopaedic Intended to be implanted to replace the trapezium polymer Class C 287. Implants carpal trapezium bone of the wrist prosthesis Wrist joint carpal Orthopaedic Intended to be implanted to replace the scaphoid polymer Class C 288. Implants carpal scaphoid bone of the wrist. prosthesis Toe joint Orthopaedic phalangeal (hemi- Intended to be implanted to replace the Class C 290. Implants toe) polymer base of the proximal phalanx of the toe. prosthesis Toe joint polymer Orthopaedic Intended to be implanted to replace the constrained Class C 291. Implants first metatarsophalangeal (big toe) joint prosthesisShoulder joint humeral (hemi- A shoulder joint humeral (hemi- Orthopaedic shoulder) metallic Class C shoulder) metallic uncemented 292. Implants uncemented prosthesis. prosthesis. Shoulder joint glenoid (hemi- Orthopaedic It is intended to be implanted to shoulder) metallic Class C 293. Implants replace part of a shoulder joint cemented prosthesis Shoulder joint metal/polymer/met al nonconstrained Orthopaedic or semi- It is a device intended to be implanted Class C 294. Implants constrained to replace a shoulder joint porous-coated uncemented prosthesis Shoulder joint metal/polymer Orthopaedic Intended to be implanted to replace a semi-constrained Class C 295. Implants shoulder joint cemented prosthesis shoulder joint metal/polymer Orthopaedic Intended to be implanted to replace a non-constrained Class C 296. Implants shoulder joint cemented prosthesis Knee joint tibial (hemi-knee) Orthopaedic metallic Intended to be implanted to replace Class C 297. Implants resurfacing part of a knee joint uncemented prosthesis Knee joint patellar (hemi-knee) Intended to be implanted to replace the Orthopaedic metallic Class C retropatellar articular surface of the 298. Implants resurfacing patellofemoral joint uncemented prosthesis knee joint femoral (hemi-knee) Orthopaedic Intended to be implanted to replace metallic Class C 299 Implants part of a knee joint. uncemented prosthesisknee joint Orthopaedic Intended to be implanted to replace a patellofemorotibial Class C 300. Implants knee joint metal/polymer Knee joint patellofemorotibial polymer/metal/pol Orthopaedic Intended to be implanted to replace a ymer semi- Class C 301. Implants knee joint constrained cemented prosthesis. Knee joint patellofemorotibial Orthopaedic polymer/metal/met Intended to be implanted to replace a Class C 302. Implants al constrained knee join cemented prosthesis knee joint patellofemoral It is intended to be implanted to replace Orthopaedic polymer/metal part of a knee joint in the treatment of Class C 303. Implants semi-constrained primary patellofemoral arthritis or cemented chondromalacia prosthesis Knee joint femorotibial (uni- compartmental) Orthopaedic Intended to be implanted to replace metal/polymer Class C 304. Implants part of a knee joint porous-coated uncemented prosthesis Knee joint femorotibial Orthopaedic metal/polymer Intended to be implanted to replace Class C 305. Implants semi-constrained part of a knee joint cemented prosthesis Knee joint femorotibial Orthopaedic metal/polymer Intended to be implanted to replace Class C 306. Implants non-constrained part of a knee joint cemented prosthesis Knee joint femorotibial Orthopaedic Knee joint femorotibial metal/polymer metal/polymer Class C 307. Implants constrained cemented prosthesis constrained cementedprosthesis Knee joint femorotibial Orthopaedic metal/polymer Intended to be implanted to replace Class C 308. Implants constrained part of a knee joint cemented prosthesis Knee joint femorotibial Orthopaedic metal/composite Intended to be implanted to replace Class C 309. Implants semi-constrained part of a knee joint. cemented prosthesis Knee joint femorotibial Orthopaedic metal/composite Intended to be implanted to replace Class C 310. Implants non-constrained part of a knee joint cemented prosthesis Hip joint metal/polymer or ceramic/polymer Intended to be implanted to replace the Orthopaedic semiconstrained Class C articulating surfaces of the hip while 311. Implants resurfacing preserving the femoral head and neck cemented prosthesis. Hip joint metal/metal semi- constrained, with a Orthopaedic Intended to be implanted to replace a cemented Class D 312. Implants hip joint acetabular component, prosthesis hip joint metal constrained Orthopaedic Intended to be implanted to replace a cemented or Class D 313. Implants hip joint uncemented prosthesis Hip joint metal/polymer Orthopaedic Intended to be implanted to replace a constrained Class D 314. Implants hip joint cemented or uncementedprosthesis Hip joint femoral Orthopaedic (hemi-hip) metallic Intended to be implanted to replace a Class D 315. Implants resurfacing portion of the hip joint prosthesis A hip joint femoral (hemi-hip) Orthopaedic metal/polymer Intended to be implanted to replace the Class D 316. Implants cemented or head and neck of the femur uncemented prosthesis A hip joint femoral (hemi-hip) Orthopaedic trunnion-bearing Intended to be implanted to replace the Class D 317. Implants metal/polyacetal head and neck of the femur cemented prosthesis Hip joint femoral (hemi-hip) Orthopaedic trunnion-bearing Intended to be implanted to replace the Class D 318. Implants metal/polyacetal head and neck of the femur cemented prosthesis. A hip joint (hemi- Orthopaedic hip) acetabular Intended to be implanted to replace a Class D 319. Implants metal cemented portion of the hip joint prosthesis Hip joint femoral (hemi-hip) metallic Orthopaedic Intended to be implanted to replace a cemented or Class D 320. Implants portion of the hip joint uncemented prosthesis. Orthopaedic rigid, limb brace, lumbar, lumbo- Plates, Class C 321. Implants sacral, rib fracture, sacroiliac, thoracic clipersScrews oethosis. The device is used to apply force to a Spinal Orthopaedic series of vertebrae to correct "sway intervertebral body Class C 322. Implants back," scoliosis (lateral curvature of the fixation orthosis spine), or other conditions.A device intended to be implanted made of an alloy, that consists of Orthopaedic Spinal interlaminal various hooks and a posteriorly placed Class C 323. Implants fixation orthosis compression or distraction rod. The device is used primarily in the treatment of scoliosis A resorbable calcium saltbone void Resorbable Orthopaedic filler device is a re sorbable implant calcium salt bone Class C 324. Implants intended to fill bony voids or gaps of void filler device the extremities, spine, and pelvis It may be used for fixation of bone fractures, for bone reconstructions, as a Smooth or guide pin for insertion of other Orthopaedic threaded metallic Class C implants, or it may be implanted 325. Implants bone fixation through the skin so that a pul ling force fastener (traction) may be applied to the skeletal system. The sacroiliac joints fixation may serve Orthopaedic Sacroiliac joint Class C as protective mechanism for the 326. Implants fixation lumbosacral region. Orthopaedic Cervical Artificial Cervical Artificial Disc is indicated for Class D 327. Implants Disc reconstruction of the disc. Intended to be used for insertion into the patient's vascular system (single 328. Scalp Vein Set Scalp Vein Set Class B use only) as an in-dwelling device to administer fluids intravenously or to sample blood. Surgical staples are specialized staples used in surgery in 329. Surgical Dressings Surgical Staples Class B place of sutures to close skin wounds, connect or remove parts of body during surgery. Dressing aerosol, non-adherent, 330. Surgical Dressings Surgical Dressings Class A dressing, periodontal, kit, dressing pad, dressing. Dressing-gel, dressing- permeable, moisture dressing, tracheostomy tube 331. Surgical Dressings Surgical Dressings Class B dressing, wound and burn dressings, hydrogel dressing, wound and burn, occlusive. 332. Surgical Dressings Cotton Grudges Adhesive bandages, Gauge bandages, Medical Absorbent (fiber) bandages.Wound Includes Beads, Hydrophilics For Dressings/Bacterio 333. Surgical Dressings Class C Wound Exudate Absorption for wound static Wound care. Dressings A prosthetic and orthotic accessory, Casting intended for medical purposes to 334. Surgical Dressings Class B tapes/Splint Rolls support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Haemostatic Intended for the control of surface 335. Surgical Dressings Gelatine Sponge Class C bleeding from vascular access sites and /Haemostat percutaneous catheters or tubes. Material dressing, surgical, polylactic 336. Surgical Dressings Surgical Dressings Class C acid dressings. An absorbable haemostatic agent or Absorable dressing is a device intended to 337. Surgical Dressings Hemostatic Class D produce haemostasis by accelerating Based the clotting process of blood. It is absorbable. These devices may be a clip, tie, tape, Umbilical or other article used to close the blood 338. Surgical Dressings Class A occlusion device vessels in the umbilical cord of a newborn infant. Surgical Dressings Non-latex plastic bolsters are used to 339. Bolster Suture Class A hinder pressure of any temporary suture against the body during surgery. Surgical Dressings Non-absorbable suture is comprised of Suture Non surgical steel as well as synthetic non- 340. Absorable Class C absorbable sutures for use in general Synthetic soft tissue approximation and ligation. Surgical Dressings The device is intended for use in 341. Suture Absorable Class C general soft tissue approximation and ligation. Surgical Dressings It is a medical device intended to Endovascular provide fixation and sealing between 342. Class C suturing system an endovascular graft and the native artery. Surgical Dressings Fixation, non- Attaching suture or stapling ligaments 343. absorbable for Class C of the pelvic floor. pelvic use Surgical Dressings Intended for topical closure of surgical Tissue adhesive for incisions including laparoscopic 344. Class C the topical use incisions and simple traumatic lacerations.Surgical Dressings Intended for use in adhesion of internal tissues and vessels, for example; Tissue adhesive for 345. Class D adhesives used in the embolization of non-topical use brain arteriovenous malformation or for use in ophthalmic surgery. Surgical Dressings It is a single use, sterile device containing 70% Isopropyl alcohol used for scrubbing 346. Alcohol Swabs Class A and allowing drying and will disinfect needless access sites prior to use.. offer a spot-welded auxiliary hook 347. Surgical Dressings Ligature Wire Class B which may be added to any bracket by simply tying in the arch wire For use in vascular reconstructions to 348. Surgical Dressings Surgical Sealant Class B achieve adjunctive hemostasis by mechanically sealing areas of leakage. Wound Closure Wound Closure Devices are indicated 349. Surgical Dressings Class B Device for soft tissue approximation. intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene Intracardiac patch is a fabric device placed in the heart 350. Surgical Dressings Class D that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(B) List of In Vitro Diagnostics Medical Devices under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017 S. N. Category in vitro diagnostic Risk Class Intended use medical device Clinical 1. Chemistry Acid Phosphatase (total Class B An acid phosphatase (total or Reagents/ or prostatic) test prostatic) test reagent/kit is a medical Kits for reagents/kits device, intended for the estimation of estimation of acid phosphatase in serum/plasma. 2. various Albumin test Class B An albumin test reagent/kit is a Parameters reagents/kits medical device intended for the exemplified estimation of albumin in as: serum/plasma. 3. Alkaline phosphatase or Class B An alkaline phosphatase or isoenzymes test isoenzymes test reagent/kit is a reagents/kits medical device intended for the estimation of alkaline phosphatase or its isoenzymes in serum/plasma. 4. Ammonia test Class B An ammonia test reagent/kit is a reagents/kits medical device intended for the estimation of ammonia levels in blood, serum/plasma. 5. Amylase test Class B An amylase test reagent/kit is a reagents/kits medical device intended for the estimation of the enzyme amylase in serum, saliva / urine. 6. Bicarbonate / carbon Class B A bicarbonate/carbon dioxide test dioxide test reagents/kits reagent/kit s a medical device for the estimation of bicarbonate/carbon dioxide in plasma, serum/whole blood. 7. bilirubin (total and Class B A bilirubin (total and direct) test direct) test reagents/kits reagent/kit is a medical device intended for the estimation of bilirubin (total and direct) in serum/plasma. 8. Calcium test Class B A calcium test reagent/kit is a medical reagents/kits device intended for the estimation of total calcium in serum.9. Chloride test Class B A chloride test reagent/kit is a reagents/kits medical device intended for the estimation of chloride in plasma, serum, sweat /urine. 10. cholesterol (total) test Class B A cholesterol (total) test reagent/kit is reagents/kits a medical device intended for the estimation of cholesterol in serum or plasma. 11. HDL cholesterol test Class B A HDL cholesterol test reagent/kit is reagents/kits a medical device intended for the estimation of HDL cholesterol in serum / plasma. 12. LDL cholesterol test Class B A LDL cholesterol test reagent/kit is a reagents/kits medical device intended for the estimation of LDL cholesterol in serum/plasma. 13. Lipoproteinstest Class B A lipoprotein test reagent/kit is a reagents/kits medical device intended for the estimation of lipoproteins in serum / plasma. 14. Cholinesterase test Class B A cholinesterase test reagent/kit is a reagents/kits medical device intended for the estimation of cholinesteral in serum /plasma. . 15. Creatine Kinase and its Class B A creatine phosphokinase/creatine isoenzymestest kinase or isoenzymes including reagents/kits CKMB, CKBB and CKMM test reagent/kit is a medical device intended for the estimation of the enzyme creatine phosphokinase or its isoenzymes in serum / plasma. . 16. Copper test Class B Copper test reagent/kit is a medical reagents/kits device intended for the estimation of copper in plasma, serum / urine. 17. Creatinine test Class B A creatinine test reagent/kit is a reagents/kits medical device intended for the estimation of creatinine in serum, plasma / urine. 18. Gamma Class B A Gamma Glutamyl Transferase GlutamylTransferase (GGT) and isoenzymes test (GGT) and isoenymes reagent/kit is a medical device test reagents/kits intended for the estimation of the enzyme Gamma GlutamylTransferase (GGT) in serum / plasma.19. Glucose test Class B A Glucose test reagent/kit is a reagents/kits medical device intended for the estimation of glucose in blood/plasma/ body fluids. 20. Glucose-6-Phosphate Class B A Glucose-6-Phosphate Dehydrogenase Dehydrogenase(G6PD)test (G6PD) and its reagents/kit is a medical device isoenzymes test intended for the estimation of reagents/kits Glucose-6-Phosphate Dehydrogenase or its isoenzymes in serum / plasma. . 21. Glycosylated Class B Glycosylated Hemoglobin or its Hemoglobin or its variants test reagents/kits are variants test medical devices intended for the reagents/kits estimation of glycosylated hemoglobin or its variants including A1a, A1b, and A1c in blood. 22. Hemoglobin test Class B A hemoglobin test reagent/kit is a reagents/kits medical device intended for the estimation of hemoglobin in blood. 23. Iron test reagents/kits Class B An iron test reagent/kit is a medical device intended for the estimation of iron in serum /plasma. 24. Ferritin test An Ferritin test reagent/kit is a reagents/kits medical device intended for the estimation of ferritin in serum / plasma 25. Iron-binding capacity Class B Iron-binding capacity test test reagents/kits reagents/kits are medical devices intended for the estimation of iron- binding capacity in serum / plasma. 26. Lactate Dehydrogenase Class B A Lactate Dehydrogenase and its and its isoenzymes test isoenzymes test reagent/kit is a reagents/kits medical device intended for the estimation of enzyme Lactate Dehydrogenase and its isoenzymes in serum / plasma. 27. Lipase test reagents/kits Class B A lipase test reagent/kit is a medical device intended for the estimation of lipase in serum / plasma. 28. Magnesium test Class B A magnesium test reagent/kit is a reagents/kits medical device intended for the estimation of magnesium levels in serum / plasma.29. Phosphorus (inorganic) Class B A phosphorus (inorganic) test test reagents/kits reagent/kit is a medical device intended for the estimation of inorganic phosphorus in serum, plasma / urine. 30. Potassium test Class B A potassium test reagent/kit is a reagents/kits medical device intended for the estimation of potassium in serum, plasma / urine. 31. Aspartate Amino Class B An Aspartate Amino Transferase Transferase (AST/SGOT) test reagent/kit is a (AST/SGOT) test medical device intended for the reagents/kits estimation of the enzyme Aspartate Amino Transferase (AST/SGOT) in serum / plasma. 32. Alanine Amino Class B An Alanine Amino Transferase Transferase (ALT/SGPT) test reagent/kit is a (ALT/SGPT) test medical device intended for the reagents/kits estimation of enzyme Alanine Amino Transferase (ALT/SGPT) in serum / plasma. 33. Sodium test Class B A Sodium test reagent/kit is a medical reagents/kits device intended for the estimation of sodium in serum/ plasma / urine. 34. Total protein test Class B A Total Protein test reagent/kit is a reagents/kits medical device intended for the estimation of total protein(s) in serum / plasma. 35. Protein (fractionation) Class B A Protein (fractionation) test test reagents/kits reagent/kit is a medical device intended for the estimation of protein fractions in blood, urine, cerebrospinal fluid / other body fluids. 36. Protein-bound iodine Class B A Protein-bound iodine test test reagents/kits reagent/kit is a medical device intended for the estimation of protein-bound iodine in serum / plasma. 37. Triglycerides test Class B A Triglyceride test reagent/kit is a reagents/kits medical device intended for the estimation of triglycerides in serum / plasma.38. Urea (BUN) test Class B A Urea (BUN) test reagent/kit is a reagents/kits medical device intended for the estimation of urea/Blood Urea Nitrogen (BUN) in plasma/ serum / urine. 39. Uric Acid test Class B A Uric Acid test reagent/kit is a reagents/kits medical device intended for the estimation of uric acid in serum/ plasma / urine. 40. Micro-Protein test Class B A Micro-protein test reagent/kit is a reagents/kits medical device intended for the estimation of micro-proteins including micro-albumin in urine. 41. Zinc test reagents/kits Class B A Zinc test reagent/kit is a medical device intended for the estimation of zinc in serum / plasma. 42. Other clinical chemistry Class B* Clinical chemistry test reagent/kit test reagents/kits intended for the estimation of analytes/ parameters (other than listed above) in serum/ plasma/ urine or other body fluids. Hematology Reagents/ Kits for estimation of 43. Blood cell Diluents Class B A blood cell Diluent is a medical Complete device used to dilute blood for further Blood testing, such as Complete Blood Counts , Count(CBC) . exemplified 44. Lyse reagents/kits for Class B A Lyse reagent/kit is a medical device as: differential counts used for lysing of cells for the estimation of Complete Blood Count(CBC). 45. Rinse/Detergent/Cleaner Class B A Rinse/Detergent/Cleaner s reagents/kits reagent/kit is a medical device used for cleaning various parts of Hematology analyzers like probes, needles, baths, tubing etc. Reagents/ Kits for estimation of parameters 46. Ascorbic Acid/ Bilirubin Class B Ascorbic Acid/ Bilirubin /Blood in the urine, /Blood Cells/Glucose/ Cells/Glucose/ Ketone / Leukocyte exemplified Ketone / Leukocyte peroxidase / Specific as: peroxidase / Specific gravity/Urobilinogen Nitrite / pH /gravity/Urobilinogen Protein / Albumin & other urinary Nitrite / pH / Protein / analytes test reagents /Strips/kits, are Albumin & other medical devices intended for the urinary analytes test preliminary estimation of diagnostic reagents /Strips/kits markers in urine. In - vitro Glucose test Class B A glucose test reagent/kit is a medical 47. Diagnostic Medical reagents/kits device intended for the preliminary Devices for self testing of glucose levels in Self -Testing blood/body fluids. 48. Human Chorionic Class B A human Chorionic Gonadotropin Gonadotropin (hCG) (hCG) test reagent/kit is a medical test reagents/kits device intended for the preliminary self testing of hCG in urine/body fluids. 49. Luteinizing Hormone Class B A Luteinizing Hormone (LH) test (LH) test reagents/kits reagent/kit is a medical device intended for the preliminary self testing of Luteinizing Hormone (LH ) in urine/body fluids. 50. Glycosylated Class B Glycosylated Hemoglobin or its hemoglobinor its variants test reagents/kits are variants Test medical devices intended for the reagents/kits preliminary self testing of Glycosylated Hemoglobin or its variants including A1a, A1b, and A1c in blood. 51. Cholesterol test Class B A Cholesterol test reagent/kit is a reagents/kits medical device intended for preliminary self testing of cholesterol in blood /body fluids. 52. Follicle Stimulating Class B A Follicle Stimulating Hormone Hormone (FSH) test (FSH) test reagent/kit is a medical reagents/kits device intended for the preliminary self testing of Follicle Stimulating Hormone (FSH) in urine /body fluids 53. Other In - vitro Class B* Diagnostic Medical Devices for Self - Testing54. In - vitro Diagnostic Medical Device for 55. Blood Gas Analysis test Class C A Blood Gas Analysis test reagent/kit near pa tient reagents/kits for near patient testing, is a medical testing device intended for the estimation of certain gases (such as oxygen and carbon dioxide etc.) dissolved in arterial blood. 56. Anticoagulant Class C An Anticoagulant monitoring test monitoring test reagent/kit for near patient testing, is reagents/kits a medical device intended for the estimation of coagulation parameters (such as PT, TT, APTT etc.) in plasma/blood. 57. Diabetes management Class C A Diabetes management test test reagents/kits reagent/kit for near patient testing, is a medical device intended for the of monitoring of diabetes in body fluids. 58. C- Reactive Protein Class C A C- Reactive Protein (CRP) test (CRP)test reagents/kits reagent/kit for near patient testing, is a medical device intended for the estimation of C -Reactive Protein (CRP) in serum and other body fluids 59. H. pylori test Class C An H. pylori test reagent/kit for near reagents/kits patient testing, is a medical device intended for the estimation of H. pylori in blood/body fluids. 60. Troponin test Class C A Troponin test reagent/kit for near reagents/kits patient testing, is a medical device intended for the estimation of Troponin T,I and its variants in blood/body fluids 61. Other in vitro Class C* In vitro Diagnostic Medical Device Diagnostic Medical for near patient test reagent/kit Devices for near patient intended for the estimation of test reagents/kits analytes/ parameters (other than listed above) in serum, plasma, urine or other body fluids. Reagents/ Kits for estimation of62. parameters Toxoplasma gondii test Class C A Toxoplasma gondii test of ToRCH& reagents/kits reagent/kit is a medical device other intended for the detection of infectious Toxoplasma gondii in serum/body agents fluids. 63. exemplified Rubella virus l test Class C A Rubella virus test reagent/kit is a as under: reagents/kits medical device intended for the detection of Rubella virus in serum/body fluids. 64. Cytomegalovirus test Class C A Cytomegalovirus test reagent/kit reagents/kits is a medical device intended for the detection of Cytomegalovirus in serum/body fluids. 65. Herpes simplex virus Class C A Herpes simplex virus test reagents/kits reagent/kit is a medical device intended for the detection of Herpes simplex virus in serum/body fluids. 66. Chlamydia pneumoniae Class C A Chlamydia pneumoniae test test reagents/kits reagent/kit is a medical device intended for the detection of Chlamydia pneumonia in serum/body fluids. 67. Methicillin-Resistant Class C A Methicillin-Resistant Staphylococcus aureus Staphylococcus aureus test reagent/kit test reagents/kits is a medical device intended for the detection of Methicillin-Resistant Staphylococcus aureus in serum/body fluids 68. Enterovirus test Class C An Enterovirus test reagent/kit is a reagents/kits medical device intended for the detection of enterovirus) in serum/body fluids. Reagents/ 69. Kits for Alpha-fetoprotein test Class C An Alpha-fetoprotein test reagent/kit detection of reagents/kits is a medical device intended for the Cancer detection of Alpha-fetoprotein in Markers serum/body fluids. 70. exemplified Beta-2 microglobulin Class C A Beta-2 microglobulin test as : test reagents/kits reagent/kit is a medical device intended for the detection of Beta-2 microglobulin in serum/body fluids 71. Bladder tumour antigen Class C A Bladder tumour antigen (BTA) test (BTA) test reagents/kits reagent/kit is a medical device intended for the detection of Bladder tumour antigen (BTA)in serum/body fluids72. CA15-3 test Class C A CA15-3 antigen (BTA) test reagents/kits reagent/kit is a medical device intended for the detection of CA15-3 in serum/body fluids 73. CA27.29 test Class C A CA27.29 test reagent/kit is a reagents/kits medical device intended for the detection of CA27.29 in serum/body fluids 74. CA125 test reagents/kits Class C A CA125test reagent/kit is a medical device intended for the detection of CA125 in serum/body fluids 75. CA72-4 test Class C A CA72-4 test reagent/kit is a reagents/kits medical device intended for the detection of CA72-4 in serum/body fluids 76. CA19-9 test Class C A CA19-9 test reagent/kit is a reagents/kits medical device intended for the detection of CA19-9 in serum/body fluids 77. Calcitonin test Class C A Calcitonin test reagent/kit is a reagents/kits medical device intended for the detection of Calcitonin in serum/body fluids 78. Carcinoembryonic Class C A Carcinoembryonic antigen (CEA) antigen (CEA) test test reagent/kit is a medical device reagents/kits intended for the detection of Carcinoembryonic antigen (CEA) in serum/body fluids 79. Chromogranin A test Class C A Chromogranin A test reagent/kit is reagents/kits a medical device intended for the detection of Chromogranin A in serum/body fluids 80. Estrogen / Progesterone Class C A Estrogen / Progesterone test receptors test reagent/kit is a medical device reagents/kits intended for the detection of Estrogen / Progesterone in serum/body fluids 81. HER2 (Human Class C A HER2 (Human Epidermal Growth Epidermal Growth Factor receptor test reagent/kit is a Factor receptor, test medical device intended for the reagents/kits detection of HER2 (Human Epidermal Growth Factor receptor in serum/body fluids82. human Chorionic A human Chorionic Goadotropin Goadotropin (hCG) test (hCG) test reagent/kit is a medical system test reagents/kits device intended for the detection of human Chorionic Goadotropin (hCG) in serum/body fluids 83. Lipid associated sialic Class C A Lipid associated sialic acid test acid test reagents/kits reagent/kit is a medical device intended for the detection of Lipid associated sialic acid in serum/body fluids 84. Neuron -Specific Class C A Neuron -Specific Enolase (NSE) Enolase (NSE) test test reagent/kit is a medical device reagents/kits intended for the detection of Neuron -Specific Enolase (NSE) in serum/body fluids 85. NMP22 test Class C A NMP22 test reagent/kit is a reagents/kits medical device intended for the detection of NMP22 in serum/body fluids 86. Prostate-Specific Class C A Prostate-Specific Antigen (PSA) Antigen (PSA) test test reagent/kit is a medical device reagents/kits intended for the detection of Prostate-Specific Antigen (PSA) in serum/body fluids 87. Prostatic Acid Class C A Prostatic Acid Phosphatase (PAP) Phosphatase (PAP) test test reagents/kits reagents/kits test reagent/kit is a medical device intended for the detection of Prostatic Acid Phosphatase (PAP) test reagents/kits in serum/body fluids 88. Prostate Cancer Antigen Class C A Prostate Cancer Antigen 3 gene 3 gene (PCA 3) test (PCA 3) test reagent/kit is a medical reagents/kits device intended for the detection of Prostate Cancer Antigen 3 gene (PCA 3) in serum/body fluids 89. Prostate-Specific Class C A Prostate-Specific Membrane Membrane Antigen Antigen (PSMA) test reagent/kit is a (PSMA) test medical device intended for the reagents/kits detection of Prostate-Specific Membrane Antigen (PSMA) in serum/body fluids 90. S-100 test reagents/kits Class C A S-100 test reagent/kit is a medical device intended for the detection of S-100 in serum/body fluids91. TA-90 test reagents/kits Class C A TA-90 test reagent/kit is a medical device intended for the detection of TA-90 in serum/body fluids 92. Thyroglobulin test Class C A Thyroglobulin test reagent/kit is a reagents/kits medical device intended for the detection of Thyroglobulin in serum/body fluids 93. Tissue Polypeptide Class C A Tissue Polypeptide Antigen (TPA) Antigen (TPA) test test reagent/kit is a medical device reagents/kits intended for the detection of Tissue Polypeptide Antigen (TPA) in serum/body fluids 94. Other Reagents/ Kits Class C* for detection of Cancer Markers Reagents/ 95. Kits for PT (Prothrombin Time) Class C A Prothrombin Time (PT)test estimation of test reagents/kits reagent/kit is a medical device Coagulation intended for the estimation of parameters prothrombin time in plasma/body exemplified fluids. 96. as: TT (Thrombin Time) Class C A Thrombin Time(TT)test test reagents/kits reagent/kit is a medical device intended for the estimation of Thrombin Time in plasma/body fluids 97. Activated Partial Class C A Activated Partial Thromboplastin ThromboplastinTime (APTT) test Time(APTT) reagent/kit is a medical device testsreagents/kits intended for the estimation of Activated Partial ThromboplastinTime in plasma/body fluids 98. Activated whole blood A Activated whole blood clotting clotting time tests time test reagent/kit is a medical reagents/kits device intended for the estimation of Activated whole blood clotting Time in plasma/body fluids 99. Fibrinogen/Fibrin Class C A Fibrinogen/Fibrin degradation degradation products products test reagent/kit is a medical tests reagents/kits device intended for the estimation of fibrinogen/fibrin degradation products in plasma/body fluids100. D-Dimer tests Class C A D-Dimer test reagent/kit is a reagents/kits medical device intended for the estimation of D-Dimer test in plasma/body fluids 101. Other Reagents/ Kits for Class C* estimation of Coagulation parameters Reagents/ Kits for 102. Aminoglycoside antibiot Class C Aminoglycoside antibiotics test monitoring ics test reagents/kits reagents/kits are medical devices of drug levels intended for the estimation of used for Aminoglycoside antibiotics in therapy or serum/body fluids. abuse 103. Antiepileptics test Class C Antiepileptics test reagents/kits are exemplified reagents/kits medical devices intended for the as under estimation of Antiepileptics in serum/body fluids. 104. Antipsychotics test Class C Antipsychotics test reagents/kits are reagents/kits medical devices intended for the estimation of Antipsychotics in serum/body fluids. 105. Mood stabilisers, test Class C Mood stabilisers test reagents/kits are reagents/kits medical devices intended for the estimation of Mood stabilisers in serum/body fluids 106. Biologic monoclonal Class C Biologic monoclonal antibody drugs antibody drugs test test reagents/kits are medical devices reagents/kits intended for the estimation of Biologic monoclonal antibody drugs in serum/body fluids 107. Buprenorphine (BUP) Class C Buprenorphine (BUP) test test reagents/kits reagents/kits are medical devices intended for the estimation of Buprenorphine (BUP) in serum/body fluids 108. Amphetamine (AMP) Class C Amphetamine (AMP) test test reagents/kits reagents/kits are medical devices intended for the estimation of Amphetamine (AMP) in serum/body fluids 109. Barbiturates ( BAR) Class C Barbiturates ( BAR) test reagents/kits test reagents/kits are medical devices intended for the estimation of Barbiturates ( BAR) in serum/body fluids110. Opiate test system test Class C Opiate test reagents/kits are medical reagents/kits devices intended for the estimation of opiates in serum/body fluids 111. Benzodiazepines Class C Benzodiazepines (BZO) test (BZO)Test reagents /kits reagents/kits are medical devices intended for the estimation of Benzodiazepines (BZO) in serum/body fluids 112. Cocaine (COC) Test Class C Cocaine (COC) test reagents/kits are reagents /kits medical devices intended for the estimation of Cocaine (COC)in serum/body fluids 113. Cotinine (COT) Test Class C Cotinine (COT) test reagents/kits are reagents /kits medical devices intended for the estimation of Cotinine (COT) in serum/body fluids 114. Ketamine ( KET )Test Class C Ketamine (KET) test reagents/kits are reagents /kits medical devices intended for the estimation of Ketamine ( KET )in serum/body fluids 115. Ecstasy ( MDMA ) Test Class C Ecstasy ( MDMA ) test reagents/kits reagents /kits are medical devices intended for the estimation of Ecstasy ( MDMA )in serum/body fluids 116. Methamphetamine ( Class C Methamphetamine ( MET ) test MET )Test reagents reagents/kits are medical devices /kits intended for the estimation of Methamphetamine (MET) in serum/body fluids 117. Morphine ( MOP )Test Class C Morphine (MOP) test reagents/kits reagents /kits are medical devices intended for the estimation of Morphine (MOP) in serum/body fluids 118. Methaqualone Class C Methaqualone (MQL) test (MQL)Test reagents reagents/kits are medical devices /kits intended for the estimation of Methaqualone (MQL)in serum/body fluids 119. Methadone ( MTD) Test Class C Methadone (MTD)test reagents/kits reagents /kits are medical devices intended for the estimation of Methadone ( MTD )in serum/body fluids 120. Oxycodone (OXY)Test Class C Oxycodone (OXY) test reagents/kits reagents /kits are medical devices intended for the estimation of Oxycodone (OXY) inserum/body fluids 121. Phencyclidine ( PCP ) Class C Phencyclidine (PCP) test reagents/kits Test reagents /kits are medical devices intended for the estimation of Phencyclidine (PCP)in serum/body fluids 122. Propoxyphene ( PPX ) Class C Propoxyphene (PPX) test Test reagents /kits reagents/kits are medical devices intended for the estimation of Propoxyphene (PPX) in serum/body fluids 123. Tricyclic Class C Tricyclic Antidepressants (TCA) test Antidepressants reagents/kits are medical devices (TCA)Test reagents intended for the estimation of /kits Tricyclic Antidepressants (TCA) in serum/body fluids 124. Marijuana (THC)Test Class C Marijuana (THC) test reagents/kits reagents /kits are medical devices intended for the estimation of Marijuana (THC) in serum/body fluids 125. Tramadol (TRA ) Test Class C Tramadol (TRA) test reagents/kits are reagents /kits medical devices intended for the estimation of Tramadol (TRA) in serum/body fluids 126. Fentanyl (FEN)Test Class C Fentanyl (FEN) test reagents/kits are reagents /kits medical devices intended for the estimation of Fentanyl (FEN) in serum/body fluids 127. Methadone Metabolite Class C Methadone Metabolite (EDDP) test (EDDP)Test reagents reagents/kits are medical devices /kits intended for the estimation of Methadone Metabolite ( EDDP )in serum/body fluids 128. Other Reagents/ Kits for Class C* monitoring of drug levels used for therapy or abuse Reagents/ Kits for 129. Anti Nuclear Antibodies Class B Anti Nuclear Antibodies test detection of test reagents/kits reagent/kit is a medical device for the autoimmune screening of auto-antibodies to disorders nuclear antigens in human specimens. exemplified as:130. Anti Transglutaminase Class B Anti Transglutaminase Antibodies Antibodies test test reagent/kit is a medical device for reagents/kits the screening of auto-antibodies to Transglutaminase in human specimens. 131. Anti Ganglioside Class B Anti Ganglioside Antibodies test Antibodies test reagent/kit is a medical device for the reagents/kits screening of auto-antibodies to Ganglioside in human specimens 132. Anti-Cyclic Class B Anti CyclicCitrullinated Peptide Citrullinated Peptide (CCP) Antibodies test reagent/kit is (CCP) Antibodies test a medical device for the screening of reagents/kits CCP auto-antibodies in human specimens. 133. Rheumatoid Factor (RF) Class B Rheumatoid Factor (RF) immunological test immunological test reagent/kit is a reagents/kits medical device for the screening of Rheumatoid Factor in human specimens. 134. Anti Smooth Muscle Class B Anti Smooth Muscle Antibody test Antibody test reagent/kit is a medical device for the reagents/kits screening of auto-antibodies to smooth muscles in human specimens. 135. Glutamic Acid Class B Glutamic Acid Decarboxylase (GAD) Decarboxylase (GAD) Antibodytest reagent/kit is a medical Antibody test device for the screening of auto- reagents/kits antibodies to Glutamic Acid Decarboxylase (in human specimens 136. Anti ovary antibodies Class B Anti ovary antibodies test reagent/kit test reagents/kits is a medical device for the screening of auto-antibodies to ovarian antigens in human specimens 137. Anti sperm Class B Anti sperm antibodies test reagent/kit Antibodies test is a medical device for the screening reagents/kits of auto-antibodies to spermatozoa in human specimens. 138. Anti-IA2 test Class B Anti IA-2 antibodies test reagent/kit is reagents/kits a medical device for the screening of auto-antibodies to IA-2 (tyrosine phosphatase) in human specimens139. Anti-Acetylcholine Class B Anti-Acetylcholine Receptor test Receptor test reagent/kit is a medical device for the reagents/kits screening of auto-antibodies to Acetylcholine Receptor in human specimens 140. Anti Thyroid gland Class B Anti Thyroid gland antibodies test antibody test reagent/kit is a medical device for the reagents/kits screening of auto-antibodies to thyroid gland antigens in human specimens 141. ANCA test reagents/kits Class B The ANCA test reagent/kit is a medical device for the screening of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) in human specimens . 142. Anti-double stranded Class B The Anti-double stranded DNA DNA (anti-dsDNA)test (Anti-dsDNA) test reagent/kit is a reagents/kits medical device for the screening of auto-antibodies to Double stranded DNA in human specimens 143. Anti-Extractable Class B The Anti-Extractable Nuclear Nuclear Antigen(Anti- Antigen(Anti-ENA)test reagent/kit is ENA)test reagents/kits a medical device for the screening of auto-antibodies to Extractable Nuclear Antigens like Smith (Sm) Antigens, Ribonuclears Protein (RNP), anti SSA (Ro) etc. in human specimens. 144. Anti-Intrinsic Factor test Class B The Anti-Intrinsic Factor test reagents/kits reagent/kit is a medical device for the screening of antibodies against intrinsic factor in human specimens. 145. Anti-Saccharomyces Class B The Anti-Saccharomyces Cerevisiae Antibodies Cerevisiae Antibodies (ASCA) test (ASCA) test reagent/kit is a medical device for the reagents/kits screening of antibodies against Saccharomyces Cerevisiae in human specimens. 146. Other Reagents/ Kits forClass B* detection of autoimmune disorders 147. Reagents/148. Kits for Triple Screen Test Class C Triple Screen Test reagent/kit for detection of reagents/kits for Down’s Down’s Syndrome is a medical markers for Syndrome device intended for the screening of Congenital Down’s Syndrome in serum/plasma. 149. disorders Quadruple Screen Test Class C Quadruple Screen Test reagent/kit for exemplified reagents/kits for Down’s Down’s Syndrome is a medical as under Syndrome device intended for the screening of Down’s Syndrome in serum/plasma 150. Chorionic Villus Sample Class C Chorionic Villus Sample Test Test reagents/kits for reagent/kit for Down’s Syndrome is a Down’s Syndrome medical device intended for the detection of Down’s Syndrome in body fluids. 151. Maternal Serum Alpha- Class C Maternal Serum Alpha-Fetoprotein Fetoprotein (MSAFP) (MSAFP) Test reagents/kits for is a test reagents/kits for medical device intended for the spina bifida screening of spina bifida in serum. 152. Others Reagents/ Kits Class C* for detection of Congenital disorders Reagents/ Kits for 153. Creatine Kinase (CK) Class B Creatine Kinase (CK) and CKMB detection of and CKMB test test reagent/kit are medical devices Cardiac reagents/kits intended for the estimation of Markers Creatine Kinase (CK) and CKMB in exemplified blood / body fluids. as under 154. Myoglobin test Class B Myglobin Test reagent/kit for is a reagents/kits medical device intended for the estimation of myglobin in blood /body fluids. 155. Troponin test Class C A Troponin test reagent/kit for near reagents/kits patient testing, is a medical device intended for the estimation of Troponin T,I and its variants in blood /body fluids 156. BNP &NT pro BNP test Class C BNP &NT pro BNP Test reagent/kit reagents/kits for is a medical device intended for theestimation of BNP &NT pro BNP in blood / body fluids Reagents/ Kits for 157. Genetic test Class C Genetic test reagent/kit for Cystic human reagents/kits for Cystic Fibrosis is a medical device intended Genetic Fibrosis for the detection of Cystic Fibrosis testing in human specimens.158. exemplified Genetic test for Class C Genetic test reagent/kit for as: Huntington’s chorea Huntington’s chorea is a medical device intended for the detection of Huntington’s chorea in human specimens. 159. Other Reagents/ Kits for Class C* human Genetic testing Reagents/ Kits for the 160. HIV Viral Load test Class C HIV Viral Load test reagent/kit is a management reagents/kits medical device intended for the of life estimation of HIV Viral Load in threatening blood/body fluids. infections 161. HBV Viral Load test Class C HBV Viral Load test reagent/kit is a exemplified reagents/kits medical device intended for the as under: estimation of HBV Viral Load in blood/body fluids. 162. HCV Viral Load test Class C HCV Viral Load test reagent/kit is a reagents/kits medical device intended for the estimation of HCV Viral Load in blood/body fluids. 163. CD4 Count & % test Class C CD4 Count & % test reagent/kit is a reagents/kits medical device intended for the estimation of CD4 Count & % in blood/body fluids. 164. CD8 Count & % test Class C CD8 Count & % test reagent/kit is a reagents/kits medical device intended for the estimation of CD8 Count & % in blood/body fluids. 165. CD4/CD8 Ratio test Class C CD4/CD8 Ratio test reagent/kit are a reagents/kits medical device intended for the estimation of CD4/CD8 Ratio in blood/body fluids. 166. Other Reagents/ Kits Class C* for the management of life threatening infections Reagents/ Kits for the 167. Treponema pallidum Treponema pallidum test reagent/kit detection of test reagents and kits Class C is a medical device intended for the sexually detection of Treponema pallidum in transmitted blood/body fluids.168. agent Neisseria gonorrhoeae Class C Neisseria gonorrhoeae test exemplified test reagents and kits reagent/kit is a medical device as under: intended for the detection of Neisseria gonorrhoeae in blood/body fluids 169. Human Papilloma Virus Class C Human Papilloma Virus (HPV) test (HPV) test reagents and reagent/kit is a medical device kits intended for the detection of Human Papilloma Virus in blood/body fluids 170. Chlamydia test reagents Class C Chlamydia test reagent/kit is a and kits medical device intended for the detection of Chlamydia in blood/body fluids 171. Herpes Virus test Class C Herpes Virus test reagent/kit is a reagents and kits medical device intended for the detection of Herpes Virus in blood/body fluids 172. Other Reagents/ Kits Class C* for the detection of sexually transmitted agent 173. Reagents/ 174. Kits for the Malaria Antigen test Class C Malaria Antigen test reagent/kit is a Antigen reagents and kits medical device intended for the detection of detection of Malaria Antigen in infectious blood/body fluids 175. agents with a Dengue virus Antigen Class C Dengue virus Antigen test risk of test reagents and kits reagent/kit is a medical device limited intended for the detection of propagation Dengue virus Antigen in blood/body exemplified fluids 176. as: Chikungunya Antigen Class C Chikungunya Antigen test test reagents and kits reagent/kit is a medical device intended for the detection Chikungunya Antigen of in blood/body fluids 177. Leptospira Antigen test Class C Leptospira Antigen test reagent/kit is reagents and kits a medical device intended for the detection of Leptospira Antigen in blood/body fluids 178. Japanese Encephalitis Class C Japanese Encephalitis Antigen test Antigen test reagents reagent/kit is a medical device and kits intended for the detection of Japanese Encephalitis Antigen in blood/body fluids179. Typhoid Antigens test Class C Typhoid Antigens Test reagent/kit is a reagents and kits medical device intended for the detection of Typhoid Antigens in blood/body fluids 180. Influenza A Antigen test Class C Influenza A Antigen test reagent/kit is reagents and kits a medical device intended for the detection of Influenza A Antigen in blood/body fluids 181. Influenza B Antigen test Class C Influenza B Antigen test reagent/kit is reagents and kits a medical device intended for the detection of Influenza B Antigen in blood/body fluids 182. Strep A Antigen test Class C Strep A Antigen test reagent/kit is a reagents and kits medical device intended for the detection of Strep A Antigen in blood/body fluids 183. Strep B Antigen test Class C Strep B test Antigen reagent/kit is a reagents and kits medical device intended for the detection of Strep B Antigen in blood/body fluids 184. Chagas Antigen test Class C Chagas disease Antigen test reagents and kits reagent/kit is a medical device intended for the detection of Chagas disease Antigen in blood/body fluids 185. Filariasis Antigen test Class C Filariasis test Antigen reagent/kit is a reagents and kits medical device intended for the detection of Filariasis Antigen in blood/body fluids 186. Kala Azar Antigen test Class C Kala Azar Antigen test reagent/kit is a reagents and kits gen medical device intended for the detection of Kala Azar Antigen in blood/body fluids 187. Rotavirus Antigen test Class C Rotavirus Antigen test reagent/kit is a reagents and kits medical device intended for the detection of Rotavirus Antigen in blood/body fluids 188. S. pneumonia Antigen Class C S. pneumonia Antigen test test reagents and kits reagent/kit is a medical device intended for the detection of S. pneumonia Antigen in blood/body fluids 189. H. pylori Antigen Class C H. pylori Antigen test reagent/kit is a Antigen test reagents medical device intended for the and kits Antigen detection of H. pylori Antigen in blood/body fluids190. Other Reagents/ Kits for Class C* Reagents/ Kits, other than above, for the detection of the Antigen detection of infectious infectious agents with a agents with a risk of limited risk of limited propagation propagation 191. Reagents/ Kits for the detection of Antibodies to infectious agents with a risk of limited propagation exemplified as under 192. Malaria Antibody test Malaria Antibody test reagent/kit is a reagents and kits medical device intended for the detection of Malaria Antibody in blood/body fluids Class B 193. Dengue Antibody test Class B Dengue Antibody test reagent/kit is a reagents and kits medical device intended for the detection of Dengue Antibody in blood/body fluids 194. Chikungunya Antibody Class B Chikungunya Antibody test test reagents and kits reagent/kit is a medical device intended for the detection of Chikungunya Antibody in blood/body fluids 195. Leptospira Antibody Class B Leptospira Antibody test reagent/kit test reagents and kits is a medical device intended for the detection of Leptospira Antibody in blood/body fluids 196. Japanese Encephalitis Class B Japanese Encephalitis Antibody test Antibody test reagents reagent/kit is a medical device and kits intended for the detection of Japanese Encephalitis Antibody in blood/body fluids 197. Typhoid Antibody test Class B Typhoid Antibody test reagent/kit is reagents and kits a medical device intended for the detection of Typhoid Antibody in blood/body fluids198. Cryptococcus Class B Cryptococcus neoformans Antibody neoformans Antibody test reagent/kit is a medical device test reagents and kits intended for the detection of Cryptococcus neoformans Antibody in blood/body fluids 199. Neisseria meningitides Class B Neisseria meningitides Antibody test Antibody test reagents reagent/kit is a medical device and kits intended for the detection of Neisseria meningitides Antibody in blood/body fluids 200. Vibrio cholera Class B Vibrio cholera Antibody test Antibody test reagents reagent/kit is a medical device and kits intended for the detection of Vibrio cholera Antibody in blood/body fluids 201. Influenza A Antibody Class B Influenza A Antibody test test reagents and kits reagent/kit is a medical device intended for the detection of Influenza A Antibody in blood/body fluids 202. Influenza B Antibody Class B Influenza B Antibody test test reagents and kits reagent/kit is a medical device intended for the detection of Influenza B Antibody in blood/body fluids 203. Strep A Antibody test Class B Strep A Antibody test reagent/kit is reagents and kits a medical device intended for the detection of Strep A Antibody in blood/body fluids 204. Strep B Antibody test Class B Strep B Antibody test reagents/kits reagents and kits is a medical device intended for the detection of Strep B Antibody in blood/body fluids 205. Chagas Antibody test Class B Chagas Antibody test reagent/kit is a reagents and kits medical device intended for the detection of Chagas Antibody in blood/body fluids 206. Filariasis Antibody Class B Filariasis Antibody test reagent/kit is test reagents and kits a medical device intended for the detection of Filariasis Antibody in blood/body fluids 207. Kala Azar Antibody Class B Kala Azar Antibody test test reagents and kits reagents/kits is a medical device intended for the detection of Kala Azar Antibody in blood/body fluids208. Rotavirus Antibody Class B Rotavirus Antibody test test reagents and kits reagents/kits is a medical device intended for thedetection of Rotavirus Antibody in blood/body fluids 209. S. pneumonia Antibody Class B S. pneumonia Antibody test test reagents and kits reagent/kit is a medical device intended for the detection of S. pneumonia Antibody in blood/body fluids 210. H. pylori Antibody test Class B H.pylori Antibody test reagent/kit is a reagents and kits medical device intended for the detection of H.pylori Antibody in blood/body fluids 211. Other Reagents/ Kits Class B* for the detection of Antibodies to infectious agents with a risk of limited propagation In vitro Diagnostic Medical Devices for Blood Grouping or Tissue Typing 212. All other than, Class C the ABO system; the Duffy system; the Kell system; the Kidd system; the Rhesus system, test reagents/kits. 213. ABO System test Class D Intended for blood grouping or tissue reagents/kits typing. 214. in vitro Rhesus (D) System test Class D reagents/kits Diagnostic Medical215. Devices for The Duffy system test Class D Blood reagents/kits Grouping or Tissue 216. The Kell system test Class D Typing reagents/kits 217. The Kidd system test Class D reagents/kits 218. HLA test reagents/kits Class D Reagents/ 219. Kits for the HIV test reagents/kits Class D HIV test reagents/kits is a medical detection of device intended for the detection of transmissible HIV in blood/body fluids. agents - 220. screening & HBV test reagents/kits Class D HBV test reagents/kits is a medical confirmatory device intended for the detection of HBV in blood/body fluids 221. HCV test reagents/kits Class D HCV test reagents/kits is a medical device intended for the detection of HCV in blood/body fluids 222. Syphilis screening Class D Syphilis test reagents/kits is a medical reagents/kits device intended for the screening of Syphilis in blood/body fluids 223. Malaria screening Class D Malaria test reagents/kits is a medical reagents/kits device intended for the screening of Malaria in blood/body fluids Other in 224. vitro TSH test reagents/kits Class B TSH test reagent/kit is a medical Medical device intended for the estimation Devices TSH in blood/body fluids. 225. Total /Free Class B Total /Free triiodothyronine (T3) test triiodothyronine (T3) reagent/kit is a medical device test reagents/kits intended for the estimation Total /Free triiodothyronine (T3) in blood/body fluids 226. Total / Free thyroxine Class B Total / Free thyroxine (T4)test (T4) test reagents/kits reagent/kit is a medical device intended for the estimation of Total / Free thyroxine (T4)in blood/bodyfluids 227. Dehydroepiandrosterone Class B Dehydroepiandrosterone (DHEA-S) (DHEA-S) (free and (free and sulfate) test reagent/kit is a sulfate) test medical device intended for the reagents/kits estimation of DHEA-S (free and sulfate) in blood/body fluids 228. Estrogen test Class B Estrogen test reagent/kit is a medical reagents/kits device intended for the estimation of Estrogen in blood/body fluids 229. Progesterone test Class B Progesterone test reagent/kit is a reagents/kits medical device intended for the estimation of Progesterone in blood/body fluids 230. Testosterone (Free and Class B Testosterone (Free and Total) test Total) test reagents/kits reagent/kit is a medical device intended for the estimation of Testosterone (Free and Total) in blood/body fluids 231. Sex Hormone Binding Class B Sex Hormone Binding Globulin Globulin (SHBG) test (SHBG) test reagent/kit is a medical reagents/kits device intended for the estimation of Sex Hormone Binding Globulin (SHBG) in blood/body fluids 232. Cortisol test Class B Cortisol test reagent/kit is a medical reagents/kits device intended for the estimation of Cortisol in blood/body fluids 233. Insulin test reagents/kits Class B Insulin test reagent/kit is a medical device intended for the estimation of Insulin in blood/body fluids 234. Luteinizing Class B Luteinizing Hormones (LH )test Hormone(LH) test reagent/kit is a medical device reagents/kits intended for the estimation of Luteinizing Hormone (LH) in blood/body fluids 235. Follicle Stimulating Class B Follicle Stimulating Hormone (FSH) Hormone(FSH) test test reagent/kit is a medical device reagents/kits intended for the estimation of Follicle Stimulating Hormone(FSH) in blood/body fluids 236. Prolactin test Class B Prolactin test reagent/kit is a medical reagents/kits device intended for the estimation of Prolactin in blood/body fluids237. Other test reagents/kits Class B Test reagents/kits for the estimation for hormones of other than above hormones in blood/body fluids 238. Vitamin B test Class B Vitamin B test reagent/kit is a reagents/kits medical device intended for the estimation of Vitamin B in blood/body fluids 239. Vitamin D test Class B Vitamin D test reagent/kit is a reagents/kits medical device intended for the estimation of Vitamin B in blood/body fluids 240. Vitamin A test Class B Vitamin A test reagent/kit is a reagents/kits medical device intended for the estimation of Vitamin A in blood/body fluids 241. Vitamin E test Class B Vitamin E test reagent/kit is a medical reagents/kits device intended for the estimation of Vitamin E in blood/body fluids 242. Vitamin K test Class B Vitamin K test reagent/kit is a reagents/kits medical device intended for the estimation of Vitamin K in blood/body fluids 243. Other test reagents/kits Class B Test reagents/kits for the estimation for vitamins of other than above vitamins in blood/body fluids 244. Homocystein test Class B Homocystein test reagent/kit is a reagents/kits medical device intended for the estimation of Homocystein in blood/body fluids 245. allergens test Class B Test reagents/kits intended for the reagents/kits estimation of allergens in blood/body fluids 246. calibrators/co Calibrators - Calibrators intended to be used with a ntrols for reagent should be treated in the same above all in class as the In vitro diagnostic vitro medical device reagent. 247. diagnostic Controls - Controls intended to be used with a medical reagent should be treated in the same devices class as the In vitro diagnostic medical device reagentNote: Anticoagulant Solutions, Embolization Particles, chitosan scaffold (for cartilage repair), Riboflavin (for Corneal Collagen cross-linking), silicone oil endotamponade, Intraocular Gases and Injectable Fillers shall be regulated as drugs under the provisions of the Drugs and Cosmetics Act, and Drugs and Cosmetics Rules, 1945. ***