Statement Indicating Status on Grant of Approval by CLAA for Manufacture of Notified Medical

Devices

(Jan. 2010 to December 2010)

Name of the Manufacturing Licence

# Product Licenced by CLAA
Manufacturer
1. M/s. Dispo Medical Devices
Private Limited
2. M/s. Spectra Vision, Plot No.
14, Shed no. 44, 45 & 46, B/H.
S.T. Workshop, Near Maruti
Service Centre, GIDC, Chitra,
Bhavnagar, Dist-Bhavnagar-
364004
3. M/s. M.J. Surgical,
Ahmedabad
No. & Validity
1. Intravenous Catheter Mfg Lic in Form 28 vide no.
2. Catheters G/28/1320 (Nov. 2009 to Nov
3. Scalp Vein Sets 2014)
1. Single piece PMMA Intra Ocular Lens (SPECTRAPMMA) Mfg Lic in Form 28 vide no.
2. Single piece PMMA Intra Ocular Lens (i-lens) G/28/1320 (Nov. 2009 to Nov
3. Single piece PMMA Intra Ocular Lens (SOFLENS) 2014)
1. Bone Screws (S.S.) Mfg Lic in Form 28 vide no.
2. Bone Screws (Titanium) G/28/1316 (Oct. 2009 to Sep.
3. Bone Plates (S.S.) 2014)
4. Bone Plates (Titanium)
5. Complete Hip joint Systems
6. Nails (S.S.)
7. Nails (Titanium)
8. Pins (S.S.)
9. Pins (Titanium)
10. Wires (S.S.)
11. Wires (Titanium)
12. Spinal Implants (S.S.)
13. Spinal Implants (Titanium)
4. M/s. Polymer Technologies
International (EOU), Block
No. 310/C, Village-Dabhasa
Tal-Padra, Dist-Vadodara-
391440
5. M/s. Lifeline Systems Private
Limited, A-49, Sector-8,
Noida, Gautam Budh Nagar
(U.P.)
6. M/s. N.S. Remedies private
Limited, Shilpangan-2nd
Floor, (CFB), L.B.-1, Sector-III,
Kolkata-700091
7. M/s. Mishra Dhatu Nigam
Limited, (Govt. of India
Enterprises) Ministry of
Defence, P.O. kanchanbagh,
Hyderabad-500058
1. Single piece PMMA Intra Ocular Lens (Sterile) (EYE-O-CARE) Mfg Lic in Form 28 vide no.
2. Foldable Hydrophilic Acrylic Intra Ocular Lens (Sterile) (Ultima) G/28/1321 (Dec. 2009 to Dec.
3. Foldable Hydrophilic Yellow Acrylic Intra Ocular Lens (Sterile) 2014)
(Gold)
4. Foldabale Hydrophobic Intra Ocular Lens (Sterile) (Acriol)
5. Endo Capsular Ring PMMA (Sterile) (Endo capsular Rings)
1. I.V. Cannula Mfg Lic in Form 28 vide no.
2. Sterile catheters for I.V.use 08/SC/PO/2008 (Nov. 2008
3. Suction Catheters to Nov. 2013)
4. Foley Catheters
5. Catheter-Peritoneal Dialysis
1. Zillion (Cobalt Chromium coronary stent system, L-605) Mfg Lic in Form 28 vide no.
2. Lysis (Stainless Steel Coronary stent System, 316L) DL-824-MB (Sep. 2009 to Sep.
2014)
1. Fracture Care Device Mfg Lic in Form 28 vide no.
2. Intra Medullary Nails 52/RR/AP/2009/MD/G
3. Spinal Products (Dec. 2009 to Dec. 2014)
4. External Fixators
5. Prosthesis
6. Maxillo-facial

8. M/s. Bombay Ortho 1. Bone Screws Mfg Lic in Form 28 vide no.
Industries, Plot No. 551/G, 2. Bone Plates G/28/1322 (Jan. 2010 to Jan.
Lodhika Village, Matoda 3. Nails 2015)
G.I.D.C., P.O. Matoda, Dist- 4. Pins/Wires
Rajkot 5. Joint replacement prosthesis
6. Spinal Implants
9. M/s. Care Group India, Block 1. Single Piece PMMA Intraocular Lens Mfg Lic in Form 28 vide no.
No. 310/E, Village Sim Ka 2. Single Piece PMMA Yellow Intraocular lens G/28/1333 (May. 2010 to
Dabhasa, tal. Padra, Dist- 3. Foldable Hydrophilic Acrylic Intraocular Lens May. 2015)
Vadodara-391440 4. Foldable Hydrophilic yellow Acrylic Intraocular Lens
5. Endo Capsular Ring PMMA
6. Foldable Hydrophilic Acrylic
10. M/s. Sky Surgicals, Plot No.
G-1950/2, Almighty Gate,
GIDC Lodhika, Metoda Distt-
Rajkot-360021 (Guj)
11. M/s. Alpha Therapeutics
Private Limited, Survey No.
869/1, Village Rajora, Near
Karnavati Hotel, Sarkhej-
Bavla Highway, Tal-Balva,
Distt-Ahmedabad-382220
12. M/s. TTK Healthcare Limited
(Ortho Division) Nop. 290,
SIDCO Industrial Estate,
Anbattur, Chennai-600098
13. M/s. MRK Healthcare, S. No.
153/P, Panch Pipal, Village
Hansapur, Unjha-Patan road,
Tal-Patan, Distt-Patan-384265
1. Bone Screews Mfg Lic in Form 28 vide no.
2. Bone Plate G/28/1342 (July 2010 to July
3. Nail for Tibia/Humerous/Femur/Suppracondular 2015)
4. Hiop Fixitaon Implants
5. Spine Implants
6. Arthroscopy Implants
7. Locking Systems
8. Maxillofacial Implants
9. Wire & Pins
1. Sterile Disposable Single use Scalp Vein Set Mfg Lic in Form 28 vide no.
2. Catheter Sterile Disposable Single use Ryle’s Tube G/28/134 (July 2010 to June
3. Catheter Sterile Disposable Single use Feeding Tube 2015)
4. Catheter Sterile Disposable Single use Suction Catheter
5. Catheter Sterile Disposable Single use Urethral Catheter
6. Catheter Sterile Disposable Single use Abdominal Drainage Kit
7. Catheter Sterile Disposable Single use Chest Drainage catheter
8. Catheter Sterile Disposable Single use Nelaton Catheter
9. Catheter Sterile Disposable Single use Foley’s Catheter
10. Catheter Sterile Disposable Single use Nasal Oxygen Catheter
11. Catheter Sterile Disposable Single use Stomach Tube
1. Total Condylar Knee System Mfg Lic in Form 28 vide no.
2. Total Hip System TN 00002456/2008 (July 2009
3. Plates to July 2014)
4. Screws
5. Conventional Implants
1. Latex Foley Balloon Catheters 2 Way, (Silicon treated) Mfg Lic in Form 28 vide no.
2. Latex Foley Balloon Catheters 3Way, (Silicon treated) G/28/1343 (July 2010 to July
3. Latex Catheter without Balloon (Silicone treated) 2015)
4. Latex Foley Balloon Catheters 2Way
5. Latex Foley Balloon Catheters 3Way
6. Latex Catheter without Balloon
14. M/s. Umacure Medical
Devices Private Limited, Plot
No. 4002, Phase-IV, GIDC,
Vatva, Ahmedabad
1. Sterile Scalp Vein Set Mfg Lic in Form 28 vide no.
2. Sterile Ryle’s Tube G/28/1334 (May 2010 to May
3. Sterile Stomach Tube 2015)
4. Sterile Levin’s Tube
5. Sterile Nasogastric Tube
6. Sterile Duodenal Tube
7. Sterile Infant Feeding Tube
8. Sterile Infant Mucus Extractor
9. Sterile Karman Cannula with & without Adopter
10. Sterile Endotracheal Tube Plain & Cuff
11. Tracheotomy Tube
12. Sterile I.V. cannula
13. Sterile Abdominal Drain Kit
14. Close Wound Suction Unit
15. Sterile Nelaton Catheter
16. Sterile Gibbon’s Catheter
17. Sterile Nasal Oxygen Catheter
18. Sterile Suction Catheter Plain & Thumb Control
19. Sterile Urotheral Catheter/Rectal Catheter
20. Sterile Umbilical Catheter
21. Sterile Foley Balloon catheter
22. Sterile Chest Drainage catheter
23. Sterile Male External Catheter
24. Sterile female Catheter
25. Sterile Twin Bore Nasal Oxygen Set
26. Sterile L.P. Spinal Needle
27. Sterile Three Way Stop Cock
28. Sterile Extension Tube
29. Sterile A.V. Fistula Needle
30. Sterile Measured Volume Set
31. Sterile Flow Regulator
32. Sterile Hemodialysis Set
33. Sterile Dialysis Catheter/Catheter kit
34. Mini Close Wound Suction Unit
15. M/s. Excel Optics Private 1. Excelens Mfg Lic in Form 28 vide no.
Limited, 15A & 15B, 2nd 2. Truelens TN 00002843 (Sept. 2010 to
Street, Loganathan Nagar, 3. Novalens Sept. 2015)
Choolaimedu, Chennai- 4. Solaris
600094 5. Freedom
6. Novaflex
7. Trufold
16. M/s. Sharma Surgicals & 1. Bone Screw Mfg Lic in Form 28 vide no.
Engineering Private Limited, 2. Bone Plates G/28/1339 (May 2010 to May
654-655, G.I.D.C., Estate, 3. Pins and Wires 2015)
Gujarat 4. Arthroscopy Screw/Implants
5. Spinal Screw
6. Spinal Plate
7. Intern Edulary Nails
8. Interlocking Bolts
9. Locking Plates
10. Other Orthopedic Implants
17. M/s. Rudraksh Pharma &
Surgico Private Limited,
176/6, G.I.D.C., Phase-I, opp.
Ingersol Rand, Naroda,
Ahmedabad-382330
1. Sterile Scalp Vein Set Mfg Lic in Form 28 vide no.
2. Sterile I.V. Cannula G/28/1348 (Aug. 2010 to
3. Sterile RYLES Tube Aug. 2015)
4. Sterile Stomach Tube
5. Sterile Levins Tube
6. Sterile Naso Gastro Tube
7. Sterile Dudenal Tube
8. Sterile Infant Feding Tube
9. Sterile Infant Mucus Extractor
10. Sterile karman Type Cannual
11. Sterile Endotracheal Tube
12. Sterile Nasal Oxygen Catheter
13. Sterile Suction Catheter
14. Sterile Yankur Suction Set
15. Sterile Twin Bore Nasal Oxygen Catheter
16. Sterile Nelaton Catheter
17. Sterile Urthtral catheter,
18. Sterile Gibbous Catheter,
19. Sterile Folly Balloon Catheter
20. Sterile Male External catheter
21. Sterile Umblical Catheter
22. Sterile Chest Drainage Catheter (Thorocic Catheter)
23. Sterile Close Wound Suction Set
24. Sterile Mini Close Wound Suction Set
25. Sterile T.U.R. Set
18. M/s Amigo Surgicare Pvt.
Ltd., Plot No. 780, Sola-Santej
Road, Rakanpur, Tal. Kalol,
Distt. Gandhinagar- 382721
19. M/s Care Group India Block
No. 310/E, Village Sim Ka
Dabhasa, Tal. Padra, Dist.
Vadodara 391440
1. I.V. Cannula [Intravenous Cannula] “Amigo” Brand Sterile Mfg Lic in Form 28 vide no.
Disposable Single Use Intra Venous Cannula Size: 14G -16G, 18G- G/28/1345 (27/07/2010 to
20G, 22G-24G 26/07/2010)
2. Catheter Sterile Disposable Single Use Ryle’s Tube “Amigo”
Brand Sterile Disposable Single Use Ryle’s Tube
3. Catheter Sterile Disposable Single Use stomach Tube “Amigo”
Brand Sterile Disposable Single Use Stomach Tube
4. Catheter Sterile Disposable Single Use feeding Tube “Amigo”
Brand Sterile Disposable Single Use feeding Tube
5. Catheter Sterile Disposable Single Use Infant Mucas Extractor
“Amigo” Brand Sterile Disposable Single Use Infant Mucas
Extractor
6. Sterile Disposable Single Use Scalp Vein Set “Amigo” Brand
Sterile Disposable Single Use Scalp Vein Set
7. Catheter Sterile Disposable Single Use Abdominal Drainage Kit
“Amigo” Brand Sterile Disposable Single Use Abdominal
Drainage Kit
8. Catheter Sterile Disposable Single Use Nasal Oxygen Catheter
“Amigo” Brand Sterile Disposable Single Use Nasal Oxygen
Catheter
9. Catheter Sterile Disposable Single Use Suction Catheter “Amigo”
Brand Sterile Disposable Single Use Suction Catheter
10. Catheter Sterile Disposable Single Use Urethral Catheter
“Amigo” Brand Sterile Disposable Single Use Urethral Catheter
1. Foldable Hydrophilic Acrylic Intraocular Lens (Sterile) Mfg Lic in Form 28 vide no.
Having Combination of G/28/1333 (03/05/2010 to
Overall Length : 11.00 mm to 14.00 mm 02/05/2015)
Optic Diameter : 5.00 mm to 7.00 mm
Power range : -15.00 to +50.00 (0.50 steps)
Optic Resolution : Monofocal or Multifocal, Spherical or Aspheric
and/or Toric
Optic Design : Biconvex, Refractive-Diffractive Modified
Aspheric Surface
Dialing holes : No holes or 2 dialing holes
20. M/s Biotech Vision Care Pvt. 1. PMMA INTRA OCULAR LENSES (NON-FOLDABLE Mfg Lic in Form 28 vide no.
Ltd., 555-557, Opposite CATEGORY) G/28/1298 (04/04/2009 to
Subham Tel-O-Pack, Khatraj- BIOVISION 03/04/2014)
Vadsar Road, AT& Post Clear and yellow PMMA Intra Ocular Lenses (Single Piece &
Khatraj, Tal. Kalol, Distt. Multi Piece) Intra Ocular Lens with Optic Diameter between 5
Gandhinagar- 382729 mm to 7 mm And overall body Diameter between 12-13.5 mm
2. PMMA INTRA OCULAR LENSES (NON-FOLDABLE
CATEGORY)
NUCLEUS
Clear and yellow Surface modified PMMA Intra Ocular Lenses
(Single Piece) Optic Diameter between 5 mm to 7 mm And
overall body Diameter between 12-13.5 mm
3. HYDROPHILIC ACRYLIC FOLDABLE INTRA OCULAR
LENSES (FOLDABLE CATEGORY)
EYECRYL (As a First Brand Name)
Clear and yellow hydrophilic acrylic foldable intra ocular lenses
(Single Piece & Multi Piece) Intra Optic Lens with Optic Diameter
between 4.4-7.0 mm And overall body Diameter between 8.4 mm
and 14.0 mm
4. HYDROPHILIC ACRYLIC FOLDABLE INTRA OCULAR
LENSES (FOLDABLE CATEGORY)
EYECRYL PLUS (As a Second Brand Name)
Clear and yellow hydrophilic acrylic foldable intra ocular lenses
(Single Piece & Multi Piece) Intra Optic Lens with Optic Diameter
between 4.4-7.0 mm And overall body Diameter between 8.4 mm
and 14.0 mm
5. HYDROPHILIC ACRYLIC FOLDABLE INTRA OCULAR
LENSES (FOLDABLE CATEGORY)
EYECRYL PLUS HYDROPHOBIC SURFACE
Clear and yellow Surface Modified hydrophilic acrylic foldable
intra ocular lenses (Single Piece)
Intra Optic Lens with Optic Diameter between 4.4-7.0 mm And
overall body Diameter between 8.4 mm and 14.0 mm
6. HYDROPHOBIC INTRA OCULAR LENSES (FOLDABLE
CATEGORY)
EYECRYL PLUS HYDROPHOBIC
Clear and yellow hydrophilic acrylic foldable intra ocular lenses
(Single Piece & Multi Piece)
Intra Optic Lenses with Optic Diameter between 4.4-7 mm And
overall body Diameter between 8.4 mm and 14 mm
21. M/s Sigma Surgical Pvt. Ltd.,
Plot no. 13, Shree Ram
Industrial Estate, B/h. CMC
Soni’s Chowl Cross Road,
Odhav, Ahmedabad – 382220
Gujarat
1. SORATH BONE SCREW – CANNULATED CANCELLOUS Mfg Lic in Form 28 vide no.
SCREWS (C.C.SCREWS) CANCELLOUS SCREWS CORTICAL G/28/1352 (27/09/2010 to
SCREWS, HIP FIXATION SCREWS 26/09/2015)
END CAP FOR INTERLOCKING NAILS, HERBERT SCREWS
INTERFERENCE SCREWS, LOCKING SCREWS FOR
INTERLOCKING NAILS, LOCKING HEAD SCREWS
MALLEOLAR SCREWS, ORAL MAXILLOFACIAL SCREWS
SCHANZ SCREWS, SHAFT SCREWS, TIBIAL POST FIXATION
SCREWS

2. SORATH BONE PLATE- CLOVERLEAF PLATES

CONDYLAR PLATES, DYNAMIC COMPRESSION PLATES
(D.C.P), H PLATES, HIP FIXATION PLATES, HOOK PLATES
KNEE FIXATION PLATES, L PLATES, LIMITED CONTACT
DYNAMIC COMPRESSION PLATES (L.C.D.C.P.)
LOCKING COMPRESSION PLATES (L.C.P)
ORAL MAXILLOFACIAL PLATES, RECONSTRUCTION
PLATES, SPOON PLATES, T PLATES, TUBULAR PLATES,

3. SORATH INTERLOCKING NAIL- INTERLOCKING NAILS FOR

FEMURAL BONE, INTERLOCKING NAILS FOR TIBIAL BONE,
INTERLOCKING NAILS FOR HUMRAL BONE, ENDERS
NAILS, RUSH NAILS, SQUARE NAILS
4. SORATH WIRES & PINS- K WIRES, S.T.PIN, WASHERS, WIRE
REEL, CROSS PINS
5. SORATH SPINAL IMPLANTS- SPINAL HOOKS, SPINAL BONE
SCREWS, CAGES, SPINAL BONE PLATES, CONNECTING
RODS, CONNECTING BLOCKS
6. SORATH PROSTHESIS- AUSTIN MOORE PROSTHESIS
(A.M.P), THOMPSON PROSTHESIS, BIOLAR PROSTHESIS,
SHOLDER PROSTHESIS, ELBOW PROSTHESIS, TOTAL HIP
PROSTHESIS, TOTAL KNEE PROSTHESIS
22. M/s Poly Medicure Ltd., 104-
105, Sec-59, Faridabad
For Export only Mfg Lic in Form 28 vide no.
1. SURUNEO insta- IV Cannula with small wings & without port 627- B(H) (06/03/2006 to
2. SURUFLON insta- IV Cannula with Injection port & wings 05/03/2011)
3. SUPER FLOW- IV Cannula with Injection port & wings
4. PANACAN- IV Cannula with Injection port & wings
5. MEDPRO- IV catheter with Injection port & wings
6. SURUON PRO- IV Cannula without Injection port & wings
7. SURUFLON PRO- IV Cannula with Injection port & suturable
wings
8. SURUNEO- IV Cannula with small wings & without port
9. SURUON- IV Cannula without Injection port & without wings
10. SURUFLON- IV Cannula with Injection port & wings
11. SURUCAN PLUS- IV Cannula with Inegrated Three way stop
cock
12. SURUCAN- IV Cannula without Injection port & with wings
13. THOMSON- IV Cannula with Injection port & wings
14. INTROCATH- IV Cannula without Injection port & with wings
15. INTROCATH PRO- IV Cannula with Injection port & with
wings
16. NUOVOcath Rapid- IV Cannula without Injection port &
without wings
17. IVFLON- IV Cannula with Injection port & wings
18. IVCATH (safety IV catheter)- IV Cannula without port &
without wings
19. IVCATH (IV catheter)- IV Cannula without port & without
wings
20. Sentrapen safe- Safety IV Cannula without port without wings
21. Sentracen safe- Safety IV Cannula with wings and without
injection port
22. Sentraflex safe- Safety IV Cannula with injection port, snap fit
cap & suturable wings
23. Sentracath- IV Cannula with 3-way stop cock
24. Sentranovo- IV Cannula with small wing & without port
25. Sentraflex- IV Cannula with small wing & without port
26. Sentraflex- IV Cannula with port & suturable wings
27. Sentraflon- IV Cannula with injection port & wings
28. Suruwin- IV Cannula without injection port & wings
29. IVENA- IV Cannula with Injection port
30. IVIVA- IV Cannula without injection port & without wings
31. Icath safety- Safety IV Cannula with wings
32. Icath- IV Cannula with wings
33. UNICAN- IV Cannula without injection port & without wings
34. UNIFLON- IV Cannula with injection port & wings
35. SURUPEN- IV Cannula without port & without wings
36. PROSEMED LORD- IV Cannula without port & without wings
 37. Easy-Port PUR- IV cannula with injection port & wings
38. Easy-Port FEP- IV cannula with injection port & wings
39. Easy-Pen PUR- IV cannula without injection port & without
wings
40. Easy-Pen PUR- IV cannula without injection port & without
wings
41. Easy- Cath FEP- IV cannula without injection port & without
wings
42. Easy-Cath PUR- IV cannula without injection port & without
wing
43. Easy-Cath W PUR- IV cannula with wing & without injection
port
44. Easy-Cath W FEP- IV cannula with wing & without injection
port
45. Easy-Cath W Neo FEP- IV cannula with small wing & without
injection port
46. Easy- Port Safety PUR- Safety IV cannula with injection port &
wings
47. Easy- Port Safety FEP- Safety IV cannula with injection port &
wings
48. Easy- Pen Safety PUR- Safety IV cannula without injection port
& without wings
49. Easy- Port Safety FEP- Safety IV cannula with injection port &
without wings
50. Easy- Cath Safety FEP- Safety IV cannula without injection port
& without wings
51. Easy- Cath Safety PUR- Safety IV cannula without injection port
& without wings
52. Easy- Cath W Safety PUR- Safety IV cannula with wings &
without injection port
53. Easy- Cath W Safety FEP- Safety IV cannula with wings &
without injection port
23. M/s Inor Medical Products 1. FH ORTHOPEDICS- AUSTIN MOORE HIP PROSTHESIS Mfg Lic in Form 28 vide no.
Ltd., Plot No. 303-304, New 2. FH ORTHOPEDICS- BONE SCREW DHS SCREWS G/28/1313 (18/08/2009 to
G.I.D.C., Gundlav, Distt. 3. FH ORTHOPEDICS- BONE PLATES 17/08/2014)
Valsad (Gujarat) 396035 (A) DHS PLATES 135 (Degree)
(B) DCS PLATES
24. M/s Aurolab, No. 1,
Sivagangai Main Road,
Veerapanjan, Madurai-
625020
25. M/s Med Plus India, Plot No.
1220, Phase-III, Near “V”
Trans Transport, G.I.D.C.
Vatva, Ahmedabad 382445
(Gujarat)
26. M/s iLife Medical Devices
Pvt. Ltd. # 86, SECTOR 56,
Phase-IV, I.E. Kundli, Sonepat
131028
27. M/s Harsoria Healthcare Pvt.
Ltd., 110-111, Phase-IV,
Udyog Vihar, Gurgaon,
Haryana
28. M/s Hardik International,
Plot no. G- 2041-42/A,
Lodhika G.I.D.C. Kishan
Gate, Kalawad Road, Metoda,
Distt. Rajkot
For export only Mfg Lic in Form 28 vide no.
1. SEELENS (Poly methyl methacrylate) TN 00002501 (13/08/2009 to
2. SEEFOLD (Hydrophilic foldable poly hydroxyl ethyl 10/08/2014)
Methacrylate with broad C haptic)
3. SEEFLEX (Hydrophilic foldable poly hydroxyl ethyl
metacrylate with dual haptic)
1. All Type of Bone Screws- Brand : MPI Mfg Lic in Form 28 vide no.
2. All Type of Bone Plates- MPI G/28/1353 (15/10/2010 to
3. All Type of PINS AND WIRES- MPI 14/10/2015)
4. All Type of ENDO PROSTHESIS- MPI
5. All Type of Intramodular- MPI
6. All Type of OFSPINE IMPLANTS- MPI
7. All Type of CERVICAL IMPLANTS
1. AG-CATH- Sterile Intravenous Cannula Mfg Lic in Form 28 vide no.
2. AG-CATH- Sterile 3 way stop cock 673-B (H) (13/08/2010 to
14/08/2015)
1. Sterile Disposable Safety IV Cannula with Catheter & with Mfg Lic in Form 28 vide no.
injection valve for Single use only 637-B (H) (17/09/2007 to
2. Sterile Disposable Safety IV Cannula with Catheter & without 18/09/2011)
injection valve for Single use only
3. Sterile Disposable IV Cannula with Catheter & without injection
valve & for Single use only
1. HARDIK- BONE SCREWS (NON STERILE) Mfg Lic in Form 28 vide no.
2. HARDIK- BONE PLATES (NON STERILE) G/28/1356 (30/10/2010 to
3. HARDIK- PINS AND WIRES (NON STERILE) 29/10/2015)
4. HARDIK- ENDOPROSTHESIS (NON STERILE)
5. HARDIK- IM NAILS (NON STERILE)
6. HARDIK- SPINE IMPLANTS (NON STERILE)
7. CERVICAL IMPLANTS (NON STERILE)
29. M/s Biorad Medisys Pvt.
Ltd., # 660, 1st & 2nd Floor,
Eshwari Industiral Estate,
Hulimavu, Bannerghatta
Road, Bangalore- 560076
30. M/s BioRad Medisys Pvt.
Ltd., 48/3 & 48/7, Sus Pashan
Road, Pune- 21
31. M/s R.R. Surgicals, 11/12
Merchant Industrial Estate,
Survey No. 10, Building, No.
1, Near Syndicate Bank,
Waliv, Vasai (East) – 401208,
Dist. Thane
32. M/s Harsoria Health Care (P)
Ltd., 110-111 Phase-IV Udyog
Vihar, Gurgaon (Hr)
1. Double J Shape Catheter, Ureteral Stent, Double J Stent, Mono J Mfg Lic in Form 28 vide no.
Stent (Indovasive) KTK/28/385/2010
2. Urethral Tumor Catheter, Endopyelotomy stent, (Indovasive) (16/08/2010 to 15/08/2015)
3. Urethral Catheter, Urethral stent, Hypospadias Catheter
(Indovasive)
4. PCN Catheter, PCN Catheter with Needle, PCN Catheter with
Locking, Nephrostomy Catheter (Indovasive)
5. Malecot Catheter, Re-entry Malecot catheter, suprapubic catheter
(Indovasive)
6. Ureteral Catheter, Selective catheter (Indovasive)
7. Nottingham one step catheter (Indovasive)
8. Duel Lumen Catheter (Indovasive)
9. Biliary Drainage Catheter, Biliary Pancreatic Stent (Indovasive)
10. Nasal Biliary Drainage Catheter (Indovasive)
11. Jejunal Feeding Catheter Tube (Indovasive)
12. Bilbao Dotter Catheter (Indovasive)
13. Percutanous Transhepatic Biliary Drainage Catheter (PTBO
Catheter) (Indovasive)
14. IUI Catheter/IUI Catheter Cannula with/Without Syringe
(Indovasive)
1. Indus Total Knee Prosthesis- Cr. Co & UHMDPE Mfg Lic in Form 28 vide no.
2. Indus Partial Hip Prosthesis (SMP) – SS 316 L PD/124, (31/07/2010 to
3. Indus Total Hip Prosthesis – CR.CO Alloy/ UHMDPE/ SS 316 L 30/07/2015)
1. Bone Screws Mfg Lic in Form 28 vide no.
2. Bone Plates KD/492, (13/08/2010 to
3. Intra Medullary Nails 12/08/2015)
4. Pins and Wires
5. Spinal Implants
1. INFLO PLUS - “Sterile Disposable IV Cannula with Catheter & Mfg Lic in Form 28 vide no.
with injection valve for single use only” 637-B(H) Valid upto
18/09/2011)
33. M/s Royal Surgical Pvt. Ltd.,
Plot no. 832, NR. Ganesh
Rubber, Santej, Tal-Kalol,
Dist. Gandhinagar - 382721
1. Generic – Sterile Scalp Vein Set For Single Use Only Size (Gauge) Mfg Lic in Form 28 vide no.
2. Generic- Sterile Measure Volume Set For Single Use Only G/28/135, 27/08/2010 to
3. Generic- Sterile I.V. Cannula For Single Use Only 26/08/2015)
4. Generic- Sterile I.V. Flow Regulator For Single Use Only
5. Generic- Sterile Peritoneal Dialysis Set For Single Use Only
6. Generic- Sterile Extension Line - With Three Way Stop Cock, For
Single Use Only
7. Generic- Sterile High Pressure Monitoring Line For Single Use
Only
8. Generic- Sterile T.U. R Set For Single Use Only
9. Generic- Sterile Closed Wound Suction Unit For Single Use Only
10. Generic- Sterile Tracheostomy Tube (with/Without Cuffed) For
Single Use Only
11. Generic- Sterile Endotracheal Tube (with / Without Cuffed) For
Single Use Only
12. Generic- Sterile Infant Mucus Extractor For Single Use Only
13. Generic- Sterile Umbilical Cord Clamp For Single Use Only
14. Generic- Sterile Corrugated Drainage Sheet For Single Use Only
15. Generic- Sterile Suction Catheter For Single Use Only
16. Generic- Sterile Urethral Catheter For Single Use Only
17. Generic- Sterile Nelaton Catheter For Single Use Only
18. Generic- Sterile Ryle’s Tube For Single Use Only
19. Generic- Sterile Infant Feeding Tube For Single Use Only
20. Generic- Sterile Chest Drainage Catheter For Single Use Only
21. Generic- Sterile Umbilical Catheter (Cannula) For Single Use
Only
22. Generic- Sterile Abdominal Drainage Kit For Single Use Only
23. Generic- Sterile Karman Cannula With/ Without Adapter For
Single Use Only
24. Generic- Sterile Nasal Oxygen Catheter For Single Use Only
34. M/s Meril Life Sciences Pvt.
Ltd., Near G.M. Bilakhia
Stadium, Muktanand Marg,
Chala, Vapi- 396191, Gujarat
35. M/s Polymer Technologies
International (EOU) Block no.
310/C, Village Sim ka
Dabhasa, Tal. Padra, Dist.
Vadodara 391440
36. M/s Nebula Surgical Pvt.
Ltd., G.I.D.C., G/739-740,
B/h Telephone Tower,
Metoda, Distt. Rajkot
(Gujarat)
37. M/s MIV Therapeutics
(India) PVT. LTD., 139-B,
Surat Special Economic Zone,
Diamond Park, GIDC, Sachin,
Surat - 394230
1. Nexgen Cobalt Chromium Coronary Stent and Stent System Mfg Lic in Form 28 vide no.
(Bare metal Coronary Stent System) G/28/1273, issue dated
2. Osum Cobalt Chromium Coronary Stent and Stent System (Bare 20/06/2008)
metal Coronary Stent System)
3. Crypton Stainless Steel Coronary Stent and Stent System (Bare
metal Coronary Stent System)
4. Biomime Sirolimus Eluting Coronary Stent and Stent System
(Biodegradable Polymer Based Sirolimus Eluting Coronary Stent
and Stent System)
1. Foldable Hydrophobic Yellow Intraocular Lens (Sterile) Mfg Lic in Form 28 vide no.
G/28/1321, valid upto
17/12/2014)
1. Bone Screws (Non Sterile) Mfg Lic in Form 28 vide no.
2. Bone Plates (Non Sterile) G/28/1355, 29/10/2010 to
3. Pins and Wires (Non Sterile) 28/10/2015)
4. Endoprosthesis (Non Sterile)
5. Im Nails (Non Sterile)
6. Spine Implants (Non Sterile)
7. Cervical Implants (Non Sterile)
1. Second Brand- Xperia Coronary Stent and Stent System Mfg Lic in Form 28 vide no.
2. Third Brand – Superia Coronary Stent and Stent System G/28/1355, valid upto
3. Third Brand – Flexia Coronary Stent and Stent System 05/10/2012)
4. Fourth Brand – ULTI – S- Core Coronary Stent and Stent System
5. Fourth Brand – ULTII – Core Coronary Stent and Stent System
38. M/s. Green Surgicals Private
Limited, Plot No. 508-512,
GIDC Savli Industrial Estate,
Manjusar, Vadodara-391775,
Gujarat
1. Bone Screws Mfg Lic in Form 28 vide no.
2. Bone Plates G/28/1331, valid upto
3. IM Nails 21/03/2015)
4. Pins & Wires
5. Staples
6. Washers & Buttons
7. Hemi Endo Prosthesis
8. Spinal Implants, Mesh & cages
9. Knee Surgery Implants
10. Sets of Implsnts
11. Peek & Carbon Fibre Reinforced Polymer (CFRP) Implants
12. Bone & Bone Substitute
13. Bone Cements
14. Maxillophysical Implants