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No. 29/Misc/03/2019-DC (211)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(Medical Devices and Diagnostics Division)
17 AUG 2022
Subject: List of the certified Medical Device Testing Laboratory (MDTL) under MDR,
2017- regarding
This office had registered a Medical Device Testing Laboratory (MDTL) to carry out
test or evaluation of a medical device on behalf of the manufacturer (Form MD-40 of MDR,
2017). There are 18 MDTLs have been registered with CDSCO till dated 07.12.2021 under
the provisions of the Medical Device Rules, 2017 (Form MD-40 enclosed).
The updated list of medical devices testing laboratories registered with CDSCO
under the provisions of Medical Devices Rules, 2017 to carry out test or evaluation of a
medical device on behalf of manufacturer is given below:
| NAME & ADDRESS
NS oI.
.
OF METDEISCTAILN DGE VICE| REGISNTOR.A TION SCOPE OF TESTING
LABORATORY
1 M/s SIPRA LABS TL/MD/2019/000001 | 1. Copper -T
| LIMITED 2. Condoms
| Address: 7-2- 3. Sterile Hypodermic Needles
| 1813/5/A, Adj. To Post 4. Tubal Rings
| | Office, Industrial 5. Hypodermic Syringes
| | Estate, Sanathnagar, 6. Blood Bags
Telangana,
Hyderabad- 500018
2 M/s Star Imaging & TL/MD/2019/000002 | 1. Bilirubin (Total and Direct) Test
Path Lab Pvt. Ltd. Reagents / Kits
Address: 4B/4, Tilak 2. Creatinine test reagent / kit
Nagar , West Delhi, 3. Aspartate Amino Transferase (AST /
Delhi (India) - 110018 SGOT) test
4. Alanine Amino Transferase
(ALT/SGPT) test
5. Uric Acid Test reagents / kits
6. Total Protein test reagents / kits
|
7. Activated partial thromboplastin time
|
| (APTT) test
8. PT (Prothrombin Time) Test reagents
/ Kits
3 M/s Alcatec TL/MD/2019/000003 | 1. Sterilized Surgical Ligatures
| Research 2. Sterilized Dis posable Device
| Laboratories India 3.Sterilized Surgical Sutures
_ Pvt. Ltd.Address: 1652 MIE
Part B, Bahadurgarh,
Haryana — 124507
MIs Sree Chitra TL/MD/2019/000004 1.Cardio Vascular Devices (Biological
Tirunal Institute For Evaluation as per ISO 10993)
Medical Sciences & 2.Neuroprosthesis (Biological
Technology
Evaluation as per ISO 10993)
Address: Medical 3. Orthopedic Implants (Biological
College,
Evaluation as per ISO 10993)
Thiruvananthapuram,
4.All medical devices and Materials
Kerala - 695011 (Biological Evaluation as per ISO
10993)
5.Dental Implants (Biological Evaluation
as per ISO 10993)
M/s, GLR TL/MD/2019/000005 1. Cardiovascular devices (Biological
Laboratories Private evaluation as per ISO 10993)
Limited
2. Orthopaedic devices (Biological
Address: GOKULAM evaluation as per ISO 10993)
STREET, Mathur, 3. Ocular devices (Biological evaluation
MATHUR, Chennai, as per ISO 10993)
Tamil Nadu - 600068 4. Surgical devices and sutures
(Biological evaluation as per ISO
10993)
5. Respiratory devices (Biological
evaluation as per ISO 10993)
6. Gastrointestinal devices (Biological
evaluation as per ISO 10993)
7. Urological devices (Biological
evaluation as per ISO 10993)
8. Haematological devices and IV sets
(Biological evaluation as per ISO
10993)
9. Dental devices (Biological evaluation
as per ISO 10993)
10. Personal care products and family
planning (Biological evaluation as
per ISO 10993)
11. Neurological devices (Biological
evaluation as per ISO 10993)
12. All medical devices and Materials
(Biological evaluation as per ISO
10993)
M/s, PALAMUR TL/MD/2019/000006 1. Catheters (Biological Toxicity)
BIOSCIENCES
2. Disposable Hypodermic needles
PRIVATE LIMITED (Biological Toxicity)
Address: 401 Aikya, 3. Surgical dressings (Biological
4th Floor, H.No-10-3- Toxicity)
32/9/23, Opp.Faust 4. Orthopaedic Implants (Biological
High School,East
Toxicity)Marredpally, 5. Blood Bags (Biological Toxicity)
Secunderabad, 6. Drug eluting stent (Biological
Hyderabad, Toxicity)
Telangana - 500026 7. Intra Ocular Lenses (Biological
Toxicity)
8. Sutures (Biological Toxicity)
9. Condoms (Biological Toxicity)
10. Heart Valves (Biological Toxicity)
11. Disposable perfusion sets (Biological
Toxicity)
12. Cardiac stent (Biological Toxicity)
13. Copper- T (Biological Toxicity)
14. Scalp Vein Set (Biological Toxicity)
M/s, Eurofins TL/MD/2020/000001 1. Disposable Perfusion Sets
Advinus Limited 2. Cardiac Stents
Address: 21 & 22, 3. Drug Eluting Stents
Phase II, Peenya 4. Blood Bags
Industrial Area, 5. Catheters (Class D)
Bengaluru 6. Catheters (Class B)
Pincode 560 058, 7. Catheters (Class C)
INDIA, Bangalore, 8. Heart valves
Bengaluru 9. Intra Ocular Lenses
(Bangalore) Urban, 10.1.V. Cannula
Karnataka - 560058 11. Bone Cements
12. Internal Prosthetic Replacements
13. Peritoneal dialysis sets
14. Condoms
15. Intra-uterine devices
16. Surgical dressing
17. Scalp Vein Set
18.Ligatures and sutures
| M/s, TRUSTIN TL/MD/2020/000002 1. Disinfectant ( Sterility and
ANALYTICAL Antimicrobial activities as per ISO
SOLUTIONS 11737-1 and 2, USP
PRIVATE LIMITED 42, EP 9.0, IP 2018, BP 2018)
Address: Plot no- 2. Catheters (Sterility, Bioburden and
303/b, Block-B, BET as per ISO 11737-1 and 2, USP
RK Complex, 1° 42, EP 9.0, IP
Floor, Thiruneermalai 2018, BP 2018) - Class A
road, Parvathy puram, 3. Surgical Sutures (Physical
| Chrompet, , parameters, Sterility and BET as per
Chennai, ISO 11737-2, USP
Kanchipuram, Tamil 42, EP 9.0, IP 2018, BP 2018) -
Nadu - 600044 Class B
4. Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758, IS
1954, ISO 11737-1and 2, IP 2018,
USP 42, BP 2018 and EN9.0) -
Class A5. Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758, IS
4954, ISO 11737-1and 2, IP 2018,
USP 42, BP 2018 and EN9.0) -
Class B
6. Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758, IS
1954, ISO 11737-1and 2, IP 2018,
USP 42, BP 2018 and EN9.0) -
Class C
7. Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758, IS
1954, ISO 11737-1and 2, IP 2018,
USP 42, BP 2018 and EN9.0) -
Class D
8. Blood bags with and without
anticoagulant solutions (Mechanical,
Sterility and BET as per ISO 3826,
IS 15102, ISO 11737-2, USP42, EP
9.0, IP 2018, BP 2018)
9. Contraceptives (Condoms -
Male/Female Condoms) (Mechanical
parameters,
Bioburden and Pathogens as per
ISO 4074-2015, WHOUNAIDS2010,
1S025841-2017,
WHOUNAIDS2012,Schedule R,
1S011737-1, IP 2018, USP42
10. Catheters (Sterility, Bioburden and
BET as per ISO 11737-1 and 2, USP
42, EP 9.0, IP
2018, BP 2018) - Class B
41.Catheters (Sterility, Bioburden and
BET as per ISO 11737-1 and 2, USP
42, EP 9.0, IP
2018, BP 2018) - Class C
12. Disposable Hypodermic Needles
(Sterility, Bioburden and BET as per
ISO 11737-1 and 2, USP 42, EP 9.0,
IP 2018, BP 2018) - Class C
13. Disposable Perfusion sets (Physical
testing, Sterility, Bioburden and BET
as per ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42, EP 9.0,
IP 2018, BP 2018) - Class B
14. Disposable Perfusion sets (Physical
testing , Sterility, Bioburden and BET
as per ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42, EP 9.0,
IP 2018, BP 2018) - Class C
15. Intraocular Lenses (Sterility,| Bioburden, BET and Pathogen
identification as per ISO 11737 -
Part 1 and 2, USP 42, EP 9.0, IP
2018, BP 2018)
16. Orthopaedic Implants (Sterility,
Bioburden and BET as per ISO
11737-1 and
2, USP 42, EP 9.0, IP 2018, BP
2018) - Class C
17. Orthopaedic Implants ( (Sterility,
Bioburden and BET as per ISO
11737-1 and 2, USP 42, EP 9.0, IP
2018, BP 2018) - Class D
18. Cardiac Stents ( Sterility test as per
1S011737-2, USP 42, EP 9.0, IP
2018, BP2018)- Class C
19. Cardiac Stents ( Sterility test as per
ISO 11737-2, USP 42, EP 9.0, IP
2018, BP2018) - Class D
20. Contraceptives (CuT) (Mechanical
parameters, Sterility, Bioburden as
per
WHO UNFPA 2016, ISO 7439, ISO
11737-1and 2, IP 2018, USP 42, BP
2018, EP 9.0)
21. Disposable Hypodermic Syringes
(Sterility and BET as per ISO 11737-
2, USP 42, EP
9.0, IP 2018, BP 2018) - Class B
22. Catheters (Sterility, Bioburden and
BET as per ISO 11737-1 and 2, USP
42, EP 9.0, IP
2018, BP 2018) - Class D
23. Disposable Hypodermic Needles
(Sterility, Bioburden and BET as per
ISO 11737-1 and 2, USP 42, EP 9.0,
IP 2018, BP 2018) - Class B
24. Disposable Perfusion sets (Physical
testing, Sterility, Bioburden and BET
as per ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42, EP 9.0,
IP 2018, BP 2018) - Class A
25. Disposable Perfusion sets (Physical
testing, Sterility, Bioburden and BET
as per ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42, EP 9.0,
IP 2018, BP 2018) - Class C
26. Intraocular Lenses (Sterility,
Bioburden, BET and Pathogen
identification as per ISO 11737 -
Part 1 and 2, USP 42, EP9.0,IP 2018, BP 2018)
27.\nternal Prosthetic Replacements
(Sterility test as per ISO 11737-2,
USP 42,
EP 9.0, IP 2018, BP 2018)
28. Heart Valves (Sterility test as per
ISO 11737-2, USP 42, EP 9.0, IP
2018, BP 2018)
29. Surgical Sutures (Physical
parameters, Sterility and BET as per
ISO 11737-2, USP 42, EP 9.0, IP
2018, BP 2018) - Class A
30. Surgical Sutures (Physical
parameters, Sterility and BET as per
ISO 11737-2, USP 42, EP 9.0, IP
2018, BP 2018) - Class C
31. Contraceptives (Tubal
Ring)(Mechanical parameters and
Sterility as per IS 13009-2000, ISO
11737-2, USP 42, EP 9.0, 1P2018,
BP 2018)
32. Disposable Perfusion sets (Physical
testing, Sterility, Bioburden and BET
as per ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42, EP 9.0,
IP 2018, BP 2018)-
Class B
33. Internal Prosthetic Replacements
(Sterility test as per ISO 11737-2,
USP 42, EP 9.0, IP 2018, BP 2018)
34. IV Cannulae (Sterility, Bioburden,
Pathogen identification as per ISO
11737-1and 2, USP 42, EP 9.0, IP
2018 , BP 2018)
35. Disposable Hypodermic Syringes
(Sterility and BET as per ISO 11737-
2, USP 42, EP9.0, IP 2018, BP
2018)
M/s, Devansh TL/MD/2020/000003 =] Catheters — Class A
Testing & Research 2. Catheters (Excluding Bio-
Laboratory Pvt. Ltd. compatibility testing) - Class B
Address: RZ-21A/331, 3. Catheters (Excluding Bio-
Madanpuri, Gali No.- compatibility testing)- Class C.
10, West Sagar Pur, 4. Disposable Perfusion Sets
Delhi, West Delhi, (Excluding Biocompatibility testing) -
Delhi - 110046 Class C
©. Disposable Hypodermic Needles
(Excluding Bio-compatibility testing)
- Class C
6. Disposable Hypodermic Needles(Excluding Bio-compatibility testing)
- Class D
Disposable Hypodermic Syringes -
Class A
Disposable Hypodermic Syringes
(Excluding Bio-compatibility testing)
- Class B
Disposable Hypodermic Syringes
(Excluding Bio-compatibility testing)
- Class C
10. Disposable Hypodermic Syringes
(Excluding Bio-compatibility testing)
- Class D
11. I.V. Cannulae - Class A
12. IV. Cannulae (Excluding Bio-
compatibility testing) - Class B
13. I.V. Cannulae (Excluding Bio-
compatibility testing) - Class C
14. I.V. Cannulae (Excluding Bio-
compatibility testing) - Class D
15. Scalp Vein Set - Class A
16. Scalp Vein Set (Excluding
Biocompatibility testing) - Class B
17. Scalp Vein Set (Excluding
Biocompatibility testing) - Class C
18. Scalp Vein Set (Excluding
Biocompatibility testing) - Class D
19. Surgical Dressings - Class A
20. Surgical Dressings (Excluding
Biocompatibility testing) - Class B
21. Surgical Dressings (Excluding
Biocompatibility testing) - Class C
22. Surgical Dressings (Excluding
Biocompatibility testing) - Class D
23. Contraceptives - Class A
24. Contraceptives (Excluding
Biocompatibility testing) - Class B
25. Contraceptives (Excluding
Biocompatibility testing) - Class C
26. Contraceptives (Excluding
Biocompatibility testing) - Class D
27. Disinfectant - Class A
28. Catheters (Excluding Bio-
compatibility testing) - Class D
29. Disposable Hypodermic Needles -
Class A
30. Disposable Hypodermic Needles
(Excluding Bio-compatibility testing)
- Class B
31. Disinfectant (Excluding Bio-
compatibility testing) - Class B32. Disinfectant (Excluding Bio-
compatibility testing) - Class C
33.
Disinfectant (Excluding Bio-
compatibility testing) - Class D
Disposable Perfusion Sets - Class A
34.
35.
Disposable Perfusion Sets
(Excluding Biocompatibility testing) -
Class B
36.
Disposable Perfusion Sets
(Excluding Biocompatibility testing)
10 M/s, JAGDAMBA TL/MD/2020/000004 1. Catheters (Test as per IS/ISO 10555)
LABORATORIES
2.
-
D
iC sl ia ns fs
e
cA
tants (As per IP, BP, USP) -
Address: 119,
Solitaire Industrial Class B
3. Disposable Hypodermic Needles
Park, Phase-1,
(Test as per IS 10654) - Class B
Dahmikallan, Bagru,
4. Disposable Perfusion Sets (Test as
Jaipur, Rajasthan-
per IS 12655) - Class A
303007
5. Disposable Perfusion Sets (Test as
per IS 12655) - Class B
6. Catheters (Test as per IS/ISO 10555)
- Class B
7. |.V. Cannulae (Test as per IS/ISO
10555) - Class B
8. Disposable Hypodermic Syringes
(Test as per 1S10258) - Class B
9. Scalp vein set (Test as per IS 16097)
- Class B
10. Surgical Dressings (Cotton and
Gauze, Bandage)-Class B
41. Surgical Dressings (Cotton and
Gauze, Bandage)-Class A
11 ITL LABS PVT LTD TL/MD/2021/000001 4. C coa mt ph ae tt ie br is li ( tyE x tc el su td ini gn )g CB li ao s- s D
B-283-284,
2. Surgical Dressings (Excluding
Mangolpuri Industrial
Area, Phase |, North
Biocompatibility testing) Class D
3. Disposable Hypodermic Syringes
West Delhi,
Delhi - 110083
Class D
4. Disposable Hypodermic Syringes
(Excluding Bio-compatibility testing)
Class D
5. Surgical Dressings Class D
6. Disposable Hypodermic Needles
(Excluding Bio-compatibility testing)
Class C
onTM
Contraceptives Class D
|.V. Cannulae (Excluding Bio-
compatibility testing) Class C
Surgical Dressings (ExcludingBiocompatibility testing) Class D
10. Scalp Vein Set (Excluding
Biocompatibility testing) Class B
11. Disposable Hypodermic Needles
Class C
12. I.V. Cannulae Class C
13. |.V. Cannulae (Excluding Bio-
compatibility testing) Class C
14. Scalp Vein Set Class B
15. Contraceptives (Excluding
Biocompatibility testing) Class D
16. Catheters Class D
17. Disinfectant Class B
18. Disposable Perfusion Sets
(Excluding Biocompatibility
testing) Class C
19. Disinfectant (Excluding Bio-
compatibility testing) Class B
20. Disposable Perfusion Sets Class C
21. Disposable Perfusion Sets
(Excluding Biocompatibility
testing) Class C
22. Disposable Hypodermic Needles
(Excluding Bio-compatibility testing)
Class D
23. Surgical Suture Class D
24. Urine collecting bag Class B
25. Surgical Gloves ( Sterile/Non Sterile)
Class D
26. Endotracheal (ET) tube Class B
27. Disposable Hypodermic Syringes
Class C
28. Blood Bag (Single Blood Bag,
Double Blood Bag, Triple Blood Bag,
Quad Blood Bag) Class C
29. Disinfectant (Excluding Bio-
compatibility testing)
| 12 Accuprec Research TL/MD/2021/000002 Vascular devices and IV sets; Class
Labs Private Limited D
Opp. Zydus Pharmez, aAPWON Tubal rings; Class C
Changodar- Bavla Copper T; Class C
Highway, Vill-Matoda,, Sutures; Class C
Sanand, Ahmedabad, Disposable Hypodermic needles;
Gujarat - 382213 Class C
> Catheters; Class D
7. Disposable Hypodermic Syringes;
Class B
8. Blood bags; Class B
9 Condoms; Class C
10. Coronary stents; Class D41. Intra Ocular Lenses Implants; Class |
D
42. Orthopaedic Implants and Devices,
Class D
13. Drug eluting stents; Class D
14. Internal Prosthetic replacements,
Class D
15. Ablation devices; Class D
13 | M/s, Conformity TL/MD/2021/000003 | 1.NIBP; Class B
Testing Labs Pvt Ltd 2.1BP; Class C
WH-52, Mayapuri 3.Nebulizer; Class C
Industrial Area, Phase 4. Thermometer; Class B
1, New Delhi, West 5.Glucometer; Class B
Delhi, Delhi - 110064
14 | Brothers TL/MD/2021/000004 | 1.Disposable Hypodermic Needles;
Laboratories Pvt. Ltd Class B
103, D-3, Industrial 2.Surgical Dressings; Class A
Area Jhotwara, Jaipur, 3. Disposable perfusion set; Class B
Rajasthan - 302012 4.Catheters; Class B
5. Surgical Dressings; Class B
6. Disinfectants; Class B
7.Disposable Hypodermic Syringe;
Class B
8.1V Canulae; Class B
9.Scalp Vein Set; Class B
15 | Mls, Shiva TL/MD/2021/000005 |1. Cardiac Stents (Test- Ethylene
Analyticals (India) Oxide residue,
Standard/Specification-ISO
Private Limited
situated at Plot Nos.
10993-7-2008) Class C, Class D
24D (P) & 34D, 2. Catheters (Test- Ethylene Oxide
residue, Standard/Specification-ISO
KIADB Industrial
10993-7-2008) — Class A, B, C, D
Area, Hoskote,
Bangalore, Hoskote, 3. Disposable Perfusion Sets (Test-
Ethylene Oxide residue,
Bengaluru
Standard/Specification-ISO 10993-7-
(Bangalore) Rural,
Karnataka - 562114 2008) Class A, Class B, Class C
4. Drug Eluting Stents (Test- Ethylene
Oxide residue,
Standard/Specification-ISO-10993-
7-2008) Class D
5. Heart Valves (Test- Ethylene Oxide
residue, Standard/Specification-ISO
10993-7-2008) Class D
6. Intra Ocular Lenses (Test- Ethylene
Oxide residue,
Standard/Specification-ISO 10993-7-
2008) Class C
7. IV Cannula (Test- Ethylene Oxide
residue, Standard/Specification-ISO |
1010993-7-2008) Class B, Class C
8. Orthopaedic Implants (Test-
Ethylene Oxide residue,
Standard/Specification-ISO 10993-7-
2008) Class B, Class C, Class D.
9. Scalp Vein Set (Test- Ethylene
Oxide residue,
standard/Specification-ISO10993-7-
2008) Class B
10. Surgical Dressings (Test- Ethylene
Oxide residue,
tandard/Specification-ISO 10993-7-
2008) Class A, Class B, Class C,
Class D
11. Disposable Hypodermic Needles
(Test-Ethylene Oxide residue,
Standard/Specification-ISO 10993-7-
2008) Class B
12. Disposable Hypodermic Syringes
(Test-Ethylene Oxide residue,
Standard/Specification-ISO 10993-7-
2008) Class B, Class C
13. Ablation Device (Test- Ethylene
Oxide residue,
Standard/Specification-ISO-10993-
7-2008)
16 M/s, APEX QUALITY TL/MD/2021/000006 1. Infusion/Syringe Pump ( Flow Rate,
CERTIFICATION Volume, Occlusion Pressure,
SERVICES PVT. LTD. Electrical Safety) (Reference
situated at 161, Standard IEC 60601-2-24,
KASTURBA NAGAR, 1S13450(Part2 Sec24)and IEC
60601-1). Class C.
NIRMAN NAGAR,
Jaipur, Jaipur, 2. Aspirator (Vacuum Testing,
Rajasthan - 302019 Electrical Safety) (Reference
Standard ISO 10079-1 and IEC
60601-1) — Class C.
3. Glucometer (Glucose Concentration
Testing) (Reference Standard
ISASO
15197.2013) — Class C
4. Blood Pressure Monitoring Devices
(Leak Test, NIBP Pressure
Accuracy) (Reference Standard
IEC60601-2-30. 2009) — Class B.
5. Nebulizer (Flow Rate, Aerosol
Output, Aerosol Output Rate,
Electrical Safety) (Reference
11Standard 1SO27427.2013 and IEC
60601-1) Class C.
Digital Thermometer, (Temperature
Testing) (Reference Standard -
IS/ISO
80601-2-56. 2017 and IS 3055 Part 1
and Part 2 and IS 6274)
17 M/s, Shri Ram TL/MD/2021/000007 4. Tubal Rings/Fallopian Rings
(Shape, Dimensions, Fracture
Scientific And
Test, Memory Test, Friction Force
Industrial Research
Test, Fatigue Test, Radio Opacity,
Foundation Sterility, Identification of polymer)
Male Latex Condoms (Dimensions,
Address: 8E, Diamond
Burst volume and pressure test,
Press Building, Water Leakage test, Quantity of
Jhandewalan lubricant, Colour Fastness, Integrity
Extension, Rani
of individual package seal,
Jhansi Road,, Delhi,
Labeling packaging and storage)
New Delhi, Delhi -
COPPER-T 380A (Physical
110055 Parameters and Dimensions,
Pouch burst strength, Amt of
copper wire, Strength of the Tie,
Copper collar pull force, Sterility)
Implantable Medical Devices
(Physical Parameters and
Dimensions, Sterility Test, BET
Test, Bio-Burden Test)
Implantable Medical Devices
(Physical Parameters and
Dimensions, Sterility Test, BET
Test, Bio-Burden Test)
IUCD-375 (Visual Inspection,
Sealed Pouch peel strength, Frame
dimensions, Copper wire weight,
Insertion Tube dimension, Thread,
Flange displacement force,
Sterility)
Disposable Hypodermic Needles
(Acidity or Alkalinity, Extractable
Metals, Physical Parameters and
Dimensions, Performance Bond -
Hub and Needle tube, Patency of
lumen, Sterility, Bacterial
Endotoxin)
Disposable syringe (Extraneous
matter, Acidity or Alkalinity,
Extractable Metals Lubricant,
Physical Parameters and
Dimensions, Sterility Test, Bacterial
Endotoxin)
12Disposable syringe (Extraneous
matter, Acidity or Alkalinity,
Extractable Metals Lubricant,
Physical Parameters and
Dimensions, Sterility Test, Bacterial
Endotoxin)
10. Surgical dressings (Threads,
weight, Length and width, foreign
matter, fluorescence, packaging,
labelling and storage)
11. Surgical dressings (Threads,
weight, Length and width, foreign
matter, fluorescence, packaging,
labelling and storage)
12. Surgical dressings (Threads,
weight, Length and width, foreign
matter, fluorescence, packaging,
labelling and storage)
13. Sterile Hypodermic Syringe for
Single use (Sterility Test, Bacterial
Endotoxin Test)
14. Cardiac Stent (Sterility Test)
15. Cardiac Stent (Sterility Test)
16. Catheters (Dimensions, Sterility
Test)
17. Catheters (Dimensions, Sterility
Test)
18. Blood Bags (Sterility Test, BET,
Chemical Analysis, Physical
Dimensions)
19. Blood Bags (Sterility Test, BET,
Chemical Analysis, Physical
Dimensions)
20. Disposable Hypodermic Needles
(Acidity or Alkalinity, Extractable
Metals, Physical Parameters and
Dimensions, Performance Bond -
Hub and Needle tube, Patency of
lumen, Sterility, Bacterial
Endotoxin)
21. Surgical dressings (Threads,
weight, Length and width, foreign
matter, fluorescence, packaging,
labelling and storage)
22. Umbilical Tapes (Physical Test,
Adhesive, Strength, Length dia)
23. Umbilical Tapes (Physical Test,
Adhesive, Strength, Length dia)
24. IV Cannula (Dimensions, Sterility)
25. \V Cannula (Dimensions, Sterility)
26. Copper-T (Sterility Test, Membrane
13Filtration Method)
N“I. Suture absorbable / Suture non-
absorbable Synthetic (Sterility Test,
Direct Inoculation Method)
NOfoo}. Tubal Ring (Sterility Test,
Membrane Filtration Method)
18. | M/s, VIVO BIO TECH | TL/MD/2021/000008 | 1. Infusion Set Class B
LTD 2. Sutures Class
Address: 3 Floor, llyas 3. Transcatheter Aortic Valve Class D
Mohammed Khan 4. Tubal Ring Class C
Estate, D. No. 8-2- 5. Blood Collection Sets Class D
672/ 5 & 6, Road 6. Blood Bags Class
No.1, Banjara Hills, 7. Intraocular Lens Class C
Hyderabad, 8. Orthopedic Implants Class
Hyderabad,
Telangana - 500034
19 | M/s, Conformity TL/MD/2021/000009 | 1. CT scan Equipment
Testing Labs Pvt Ltd 2. MRI Equipment
Address: WH-52, 3. Defibrillators
Mayapuri Industrial 4. Bone Marrow cell separator
Area, Phase 1, New 5. PET Equipment
Delhi, West Delhi, 6. X-Ray Equipment
Delhi - 110064 7. Dialysis Machine
20 | Mis, Oasis Test TL/MD/2022/000001 | 1. Orthopaedic Implants
House Limited 2. Intraocular lens
situated at SP-2, 22 3. Catheter class A
Godam Industrial 4. Bone cement
Estate, Jaipur- 5. Blood bags
302006. , Jaipur, 6. Catheter Class B
Jaipur, Rajasthan - 7. Disposable Hypodermic Needles
302006 8. Disposable Perfusion Sets
9. Disposable Hypodermic Syringes
10.1V Cannulae
11. Scalp Ven Set
12. surgical dressings
13. Sutures and Ligatures
14. Intrauterine Device
21 | Mis, Oasis Test TL/MD/2022/000003 O©ONOARONA Catheters - Class A
House situated at 24 Intra Ocular Lenses - Class C
A -B, Sardar Patel Orthopedic Implants -Class C
Industrial Estate, Surgical Dressings - Class B
Narol, Ahmedabad,
Orthopedic Implants - Class D
Scalp vein set - Class B
Gujarat
Disinfectants - Class B
- 382405
Infusion sets - Class B
. Blood bags - Class C
10. Catheters - Class B
11. Disp Hypodermic Needles-Class
B
12. Disposable Perfusion Sets-Class
14B
13. Disp Hypodermic Syringes-Class
B
14. Disposable Perfusion Sets- class
A
15.IV Cannulae - Class B
22 M/s Astute Labs Pvt. TL/MD/2022/000004 X a- nr da y
R
aE dq iu oi sp cm oe pn yt
—
f Co lr aR sa sd Ciography
Ltd.,
Cardiac Defibrillators - Class C
On
Invasive Blood Pressure
Sr. No. 82/1, Bajirao
Monitoring Equipment - Class C
Dhawade Patil
Mammographic X-ray Equipment
Industrial Estate, NDA
and Mammographic Stereotactic
Road, Shivane, Pune,
Maharashtra - 411023
Devices - Class C
Peritoneal Dialysis Equipment -
Class C
Ultrasonic Medical Diagnostic and
Monitoring Equipment - Class B
X-ray Equipment for Interventional
Procedures - Class C
23 M/s INSTITUTE FOR TL/MD/2022/000005 F Po al re ay m etC ea rth e Bte Er T T aw no d w Sta ey ri li( tyT )e st -
INDUSTRIAL
RESEARCH & Class
TOXICOLOGY
F209,
PHASE 1, UPSIDC,
M.G. ROAD,
Ghaziabad, Uttar
Pradesh, 201001
Ghaziabad (India) -
245101
10.
D
DISPOSABLE ELECTRODE
RECORDING CATHETER (Test
Parameter-BET and Sterility) -
Class D
INTRODUCER SHEATH
CATHETER (Test Parameter-BET
and Sterility) - Class D
DOUBLE LUMEN CATHETER
SET (Test Parameter-BET and
Sterility) - Class D
DISPOSABLE CENTRAL
VENOUS CATHETER (Test
Parameter-BET and Sterility) -
Class D
DOLPHIN SUTURES
parameter Sterility) - Class C
DISPOSABLE EMBOLECTOMY
CATHETER (Test Parameter-BET
and Sterility) - Class D
DISPOSABLE
THERMODILUTION CATHETER
(Test Parameter-BET and
Sterility) - Class D
Foley Catheter Two way (Test
Parameter BET and Sterility) -
Class
(Test
B
Male Catheter (Test Parameter-
BET and Sterility) - Class B
1511. Ryles Tube 14FG (Test
Parameter-BET, Bioburdan and
Sterility) - Class B
12. Endotracheal tube (Test
Parameter-BET, Bioburdan and
Sterility) - Class B
13. Coronary Artery Cannula (Test
Parameter-BET and Sterility) -
Class
14.
15.
16.
B
Natural rubber latex condom (Test
Parameter-BET ) - Class B
Urethreal Catheter (Test
Parameter-BET and Sterility) -
Class D
Multiple Lumen Catheter (Test
Parameter-BET and Sterility) -
Class B
24 M/s Vorick Analytical TL/MD/2022/000006 Lint Bandage - Dimensions, pH
Research Pvt. Ltd. Value, Scouring Loss, Freedom
from optical Witness Class A
Plot No. 252, Sector — Heart Valves - Heavy toxic metals
K, Bhorgarh Industrial as Arsenic, lead, Cadmium,
Area, Bawana -— Il, Mercury Particulate
Narela, North Delhi, Contamination, Sterility Class D
Delhi (India) - 110040 Disposable Perfusion set -
Particulate contamination, Tubing
length, Flow rate, Heavy Metals,
Acidity or alkalinity, Residue on
evaporation, UV absorption of
extract solution, Sterility Class B
Heavy toxic metals as Arsenic,
lead, Cadmium, Mercury,
Particulate Contamination,
Mercury Class D
Ablation Devices -Heavy toxic
metals as Arsenic, lead,
Cadmium, Mercury, Particulate
Contamination, Sterility Class C
Ablation Devices- Heavy toxic
metals as Arsenic, lead, |
Cadmium, Mercury, Particulate
Contamination, Sterility Class D
Cardiac Stents - Heavy toxic
metals as Arsenic, lead,
Cadmium, Mercury, Particulate
Contamination, Sterility Class D
Disposable Hypodermic Syringe -
Capacity, Fiducial Line, Limits for
acidity or alkalinity, Metal,
Lubricant, Scale, Barrel, Piston,
Nozzle, Performance, Reducing |
16substances, Sterility Class B
Bone Cements-Heavy toxic
metals as Arsenic, lead,
Cadmium, Mercury, Sterility Class
Cc
10.
Contraceptives- Heavy _ toxic
metals as Arsenic, lead,
Cadmium, Mercury, Water
Leakage test, Bursting volume
and pressure test, dimension,
Sterility Class C
11. Contraceptives- Heavy toxic
metals as Arsenic, lead,
Cadmium, Mercury, Water
Leakage test, Bursting volume
and pressure test, dimension,
Sterility Class D
12.
Disinfectant-Efficacy Test Class B
13. Disposable Hypodermic Needles -
Limits for acidity or alkalinity,
Limits for extractable metals, Size
designation, Colour coding,
Needle hub, tube, point, Sheath,
Performance, Sterility Class B
14. IVD Kits - Sterility Class B
15. IVD Kits - Sterility Class C
16. IVD Kits - Sterility Class D
17. Blood Bags - Length, Width,
Diameter, Leakage test, Limit of
acidity or alkalinity, Heavy toxic
metals as Arsenic, lead,
Cadmium, Mercury, Sterility Class
Cc
18. Disposable Hypodermic Needles -
Limits for acidity or alkalinity,
Limits for extractable metals, Size
designation, Colour coding,
Needle hub, tube, point, Sheath,
Performance, Sterility Class C
19. Internal Prosthesis - Heavy toxic
metals as Arsenic, lead,
Cadmium, Mercury Particulate
Contamination, Sterility, Class D
20. IV Cannula - Limits for acidity or
alkalinity, Intravascular Catheter,
Distal end, Hub, Effective length,
Outside Diameter, Corrosion Test,
Peak tensile force, Freedom from
leakage, Sterility Class C
2A;
Surgical Dressing-Bleached
Gauze, Length, Width, Weight in
17gm/m2, Scouring loss/Foreign
matter, Absorbency, Freedom
from optical Whitness, pH value of
aqueous extract, Sterility Class A
22.
Orthopedic Implants- Heavy toxic
metals as Arsenic, lead,
Cadmium, Mercury, Particulate
Contamination, Sterility Class D
23; Surgical Dressing IHS/ As_ per
manufacturer specifications Class
D
24. Internal Prosthesis - Heavy toxic
metals as Arsenic, lead,
Cadmium, Mercury Particulate
Contamination, Sterility Class C
25. Disposable Perfusion set -
Particulate contamination, Tubing
length, Flow rate, Heavy Metals,
Acidity or alkalinity, Residue on
evaporation, UV absorption of
extract solution, Sterility Class A
26. Surgical Dressing - Bleached
Gauze, Length, Width, Weight in
gm/m2, Scouring loss/Foreign
matter, Absorbency, Freedom
from optical Whitness, pH value of
aqueous extract, Sterility Class Cc
27 IV Cannula - Limits for acidity or
alkalinity, Intravascular Catheter,
Distal end, Hub, Effective length,
Outside Diameter, Corrosion Test,
Peak tensile force, Freedom from
leakage, Sterility Class B
28. Crepe Bandages - Dimensions,
Weight per unit area,
Stretchability, breaking load,
Chemical Neutrality. Class A
29. POP Bandages - Setting Time,
Tensile Strength, Compressive
strength Class A
30. Disposable Perfusion set -
Particulate contamination, Tubing
length, Flow rate, Heavy Metals,
Acidity or alkalinity, Residue on
evaporation, UV absorption of
extract solution, Sterility Class C
31. Catheters- Length, Diameter,
Heavy toxic metals as Arsenic,
lead, Cadmium, Mercury,
Particulate Contamination, Sterility
Class A |
1832. Catheters- Length, Diameter,
Heavy toxic metals as Arsenic,
lead, Cadmium, Mercury,
Particulate Contamination, Sterility
Class B
33. Catheters- Length, Diameter,
Heavy toxic metals as Arsenic,
lead, Cadmium, Mercury,
Particulate Contamination, Sterility
Class C
34. Catheters- Length, Diameter,
Heavy toxic metals as Arsenic,
lead, Cadmium, Mercury,
Particulate Contamination, Sterility
Class D
35. Orthopedic Implants- Heavy toxic
metals as Arsenic, lead,
Cadmium, Mercury, Particulate
Contamination, Sterility Class C
36. Surgical Dressing - Bleached
Gauze, Length, Width, Weight in
gm/m2, Scouring loss/Foreign
matter, Absorbency, Freedom
from optical Whitness, pH value of
aqueous extract, Sterility Class B
37. Disposable Hypodermic Syringe -
Capacity, Fiducial Line, Limits for
acidity or alkalinity, Metal,
Lubricant, Scale, Barrel, Piston,
Nozzle, Performance, Reducing
substances, Sterility Class B
38. Rolled Bandage - Dimensions, pH
Value, Scouring Loss, Freedom
from optical Witness Class A
Vu
(Dr V G Somani)
Drugs Controller General (I)
To,
IT Cell for uploading the information on the CDSCO website.
19