Agents from Jan. 2011 to 20Th December 2011

Registration Certificates issued for the Medical Devices alongwith their manufacturing sites and Indian Authorized

Agents from Jan. 2011 to 20th December 2011

S. No. / Name of Indian Agent / Name of Manufacturer / Name of the Device / File No. / R. C. No. / Validity of the Registration Certificate
1 / M/s Sahajanand Medical Technologies Pvt. Ltd., Sahajanand House, Parsi Street, Saiyedpura, Surat- 395003, Indai / M/s. Natec Medical Ltd., Maeva Centre Building, Business Park, Ebene, Reduit, Maruitius / Catheter:
PTCA Catheter: Tamarin Blue (Non Sterile) / 31-273-MD/2007-DC (Re-Registration 2009) / MD-273 / 31-12-2013
2 / M/s VSY Ophthalmic India Pvt. Ltd., 860/1-B, GIDC Estate, Nr. ABB Goods Gate, Makarpura, Vadodara- 390010, Gujarat / M/s VSY Biotechnology-VSY Biyoteknoloji ve IIac San. A.S. of Ataturk Mah., Sulun c., Kamilbey Sok No. 4, Atasehir, Istanbul, Turkey / 1.  ACRIVA Ultra Definition Intra Ocular Lents
2.  ACRIVA Reviol Multifocal Intra Ocular Lens
3.  OCUVA Aspheric Intra Ocular Lens
4.  OCUVA Spheric Intra Ocular Lens / 31-824-MD/2010-DC / MD-824 / 31-12-2013
3 / M/s India Medtronic Pvt. Ltd., 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Anheri-Ghatkopar Link Road, Andheri (E), Mumbai- 400093 / M/s Medtronic Inc., 710 Medtronic Parkway N. E. Minneapolis MN 55432 USA having manufacturing premises at M/s Medtronic ATS Medical Inc., 3905 Annapolis Lane, Suite 105 Minneapolis, MN – 5547, USA / 1.  Open Pivot Heart Valve
2.  Open Pivot Aortic Valved Graft (AVG) / 31-892-MD/2010-DC / MD-892 / 31-12-2013
4 / M/s B. Braun Medical India Pvt. Ltd., 5th Floor, East Quadrant, The IL & FS Financial Centre, Bandra Kurla Complex, Bandra (E), Mumbai- 400051 / M/s B. B raun Melsungen AG, Carl-Braun- Strasse 1, 34212 Melsungen, Germany / 1.  Intrafix-IV Infusion administration sets vented for pressure and gravity infustions / 31-146-MD/2006-DC (Re-Registration 2009) (End. 1) / MD-146 / 30-11-2012
5 / M/s Edward Lifesciences (India) Pvt. Ltd., E.F. 201-204, Remi Biz Court, Plot No. 9, Off Veera Desai Road, Andheri West, Mumbai- 400058 / M/s Edward Lifesciences LLC, One Edwards Way, Irvine CA, USA 92614-5686 / 1.  Carpentier-Edwards Bioprosthetic Valved Conduit
2.  Edwards MC Tricuspid Annuloplasty System / 31-93-MD/2006-DC (Re-Registration 2010) (End. 1) / MD- 93 / 31-01-2013
6 / M/s Boston Scientific International B.V., 100A, The Capital Court, Olof Plame Marg, Munirka, New Delhi- 110067 / M/s Boston Scientific Corporation, Boston Scientific Place, Natick, Massachusetts 01760-1537, USA having factory premises at M/s Boston Scientific Ireland Ltd., Ballybrit Business Park, Galway, Ireland / 1.  WallFlex Enteral Colonic/ Duodenal Stent System / 31-41A-MD/06-DC (End. 2) / MD-41A / 31-03-2013
7 / M/s Abbott Medical Optics Pvt. Ltd., No. 91, G.N.T. Road, Madhavaram, Chennai- 600110 / M/s Abbott Medicals Optics Inc., 1700E St. Andrew Place, Santa Ana, California 92705, USA having factory premises at M/s AMO Manufacturing Spain, S.L. Crta. Fuencarral A, KM 15.4, 28100 Alcobendas (Madrid0, Spain / 1.  Blink Intensive Tears / 31-737-MD/2009-DC / MD-737 / 31-12-2013
8 / M/s B. Braun Medical (India) Pvt. Ltd., 5 th Floor , East Quadrant, The IL & FS Financial Centre, Bandra Kurla Complex, Bandra (East), Mumbai- 400051 / M/s B. Braun Medical, 204 Avenue du Marechal Juin-BP 331, 92107 Boulogne, Cedex, France having factory premises at M/s B. Braun Medical Industries Sdn. Bhd., Bayan Lepas Free Industrial Zone, 11900 Penang, Malaysia / Needles for Implantable access ports
1.  Surecan
2.  Cytocan / 31-393-MD/2007-DC (Re-Registration 2010) / MD- 393 / 31-12-2013
9 / M/s RFCL Ltd., A-3, Okhla Industrial Area, Phase-I, New Delhi / M/s Biokit S.A. Can Male s/n, 08186, Llica d Amunt, Barcelona, Spain / 1.  Bioelisa HBsAg 3.0 / 6-6/CD-35/2009-DC (Re-Reg 2009) (End 01) / CD-31 / 31-05-2012
10 / M/s Epsilon Eye Care Pvt. Ltd., 6B-301 Shweta Asha Nagar, Western Express Highway, Kandivali East, Mumbai - 400101 / M/s Aaren Scientific Inc., 4290 E. Brickell Street, Building A, Ontario, California 91761 USA / 1.  Oii PMMA (Intraocular Lenses)
2.  Oii Heparin PMMA (Intraocular Lenses)
3.  Oii Biovue (Intraocular Lenses) / 31-14-MD/2006-DC (Re-Registration 2009) / MD-14 / 30-06-2012
11 / M/s Becton Dickinson India Pvt. Ltd., 5th Floor, Singnature Towers II, South City-1, Gurgaon- 122001 Haryana / M/s Becton Dickinson and Company, BD Medical Diabetes Care, 1 Becton Drive, Franklin Lakes, New Jersey 07417, having factory premises at M/s BD Medical Diabetes Care, 1329 West Highway # 6, Holdrege, Nebraska, 68949, USA / 1.  Alcohol Swab / 31-825-MD/2010-DC / MD-825 / 14-12-2013
12 / M/s. Labindia Healthcare Private Limited, 372 Udyog Vihar, Phase- 2, Gurgaon, 122016, Haryana / M/s.KCI USA Inc., 4958 Stout Drive San Antonio, TX 78219 USA having factory premises at M/s Polymedics BVBA, 1031 Ambachtslaan, Peer, Belgium 3990 / 1.  VAC WhiteFoam Small & Large / 31-792-MD/2010-DC / MD- 792 / 31-12-2013
13 / M/s. St. Jude Medical India Private Limited, A&B, 2nd Floor, “Brij Tarang”, Greenlands, Begumpet, Hyderabad 500016 / M/s. St. Jude Medical, 14901 De Veau Place Minnetonka, MN 55345-2126 USA / 1.  Engage Family Introducers / 31-22-MD/2006-DC (Re-Registration 2009) (End 3) / MD- 22 / 30-06-2012
14 / M/s Baxter (India) Pvt. Ltd., 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase II, Gurgaon 122002 / M/s Baxter Healthcare Corporation 1900 N. Highway 201 Monutain Home, ar 72653-2497 / 1.  Minicap Extended Life Transfer Set / 31-730-MD/2009-DC / MD- 730 / 31-12-2013
15 / M/s Tyco Healthcare India Pvt. Ltd., “DOSHI TOWERS” 6th Floor, Doshi twoers, Poonamallee High Road, Chennai- 600010 / M/s Mediquip Sdn. Bhd. PO Box 2501700 Kangar, Perlis, Malaysia / 1.  Kendall Curity Latex Foley Catheter / 31-333-MD/2007-DC (Re-Registration 2010) / MD- 333 / 31-12-2013
16 / M/s. Globus Medical India Private Limited, New No. 3, Sriram Nagar, South Street, Alwaret, Chennai- 600018 / M/s. Globus Medical, Valley Forge Business Centre 2560 General Armistead Avenue Andubon, PA 19403, USA / 1.  Microfuse Bone Void Filler (Spine Indications), Sterile
2.  H-Link Integrated Rod
3.  Transition Stabilization System STERILE Implant
4.  Nilo Corpectomy Spacer
5.  Patriot Singature TLIF Spacer
6.  Revolve Stabilization System
7.  VIP Anterior Cervical Plate System
8.  Corridor Fixation System / 31-277-MD/2006-DC (Re-Registration 2010) (End 1) / MD- 277 / 28-02-2013
17 / M/s. Baxter India Private Limited, 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase-II, Gurgaon-122002 / M/s. Baxter Healthcare Corporation, 21026, Alexander Court, Hayward, CA 94545, USA
Having factory premises at M/s. Baxter Healthcare Corporation, 21026, Alexander Court, Hayward, CA 94545, USA / 1.  Curved Applicator Tip 8cm & 10cm / 31-734A-MD/2009-DC (Re-Registration 2011) / MD-734A / 14-01-2014
18 / M/s. Smith & nephew Healthcare Private Limited, BG 1-3, 15-17 Rajlaxmi Commercial Complex, kalher Village, Thane-Bhiwandi Road, Thane-421302 / M/s. Smith & Nephew Orthopaedics Limited, 1 Kingmaker Court, Warwick Technology Park, Gallows Hill, Warwick, CV34 6 WG, UK having factory premises at M/s. Smith & Nephew Orthopaedics Limited, Aurora Spa Park, Harrison Way, Leamington Spa, Warwick, DV31 3HL, UK / Birmingham Hip Resurfacing System / 31-441-MD/2008-DC (Re-Reg. 2010) / MD-441 / 31-03-2014
19 / M/s. Prime Surgicals, 3/15 Asaf Ali Road, New Delhi-2 / M/s. Curamed Opthalmics, Voorstraat 57, 4132 AN, Vianen, Netherlands / Curamed Intraocular Lens Hydrophilic Acrylic / 31-152-MD/2006-DC (Re-Reg. 2010) / MD-152 / 14-02-2014
20 / M/s. Alpha and Omega Diagnostics India Limited, Rajmahal 13, Bhuleswar Road, Mumbai-400002 / M/s. Labotect GmbH, labour technik-Gottingen, Wille-Eicher Str. 25, D-37079 Gottingen, Germany / Embryo Transfer Catheter / 31-269-MD/2006-DC (Re-Reg. 2010) / MD-269 / 14-02-2014
21 / M/s. DePuy Medical private Limited, 64-66 Senapati Bapat Marg, mahim, Mumbai-400016 / M/s. DePuy Orthopaedics, Inc PO BOX 988, 700 Orthopaedic Drive, Warsaw, Indiana 46581-0988, USA having factory premises at M/s. Johnson & Johnson Medical (Suzhou) Limited, No. 299, Chang Yang Street, Suzhou Industrial Park, Suzhou Jiangsu 215126, China / 1.  PFC Tibial Trays-Standard & Modular
2.  Apex Hole Eliminator
3.  Articul/Eze Heads
4.  Duraloc Hip System-Poly Liners & Cups
5.  PFC Sigma Toal Knee Replacement
6.  Global Shoulder Systems
7.  Screws: Cortical Screws, Cancellous Screws and pinnacle Screws / 31-852-MD/2010-DC / MD-852 / 31-01-2014
22 / M/s. WorldMed Equipments Private Limited, Office No. 49 & 50, 3rd Floor, Property no. WZ 26, Village Nangli Jalib, janak Puri, New Delhi-110058 / M/s. CID S.r.l., Strada per Crescentino snc, 13040, Saluggia (VC), Italy / 1.  Janus Optima Carbostent
2.  Brio Pegaso SCRX
3.  Pro HP Pegaso / 31-06-MD/2006-DC (Re-Reg. 2009) (End 01) / MD-06 / 14-04-2013
23. / M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036 / M/s. Johnson & Johnson International, C/o European Logistics Centre, Lenneke Marelaan 6, BE-1932 St Stevens Woluwe, Belgium having factory premises at M/s. Johnson & Johnson Medical GmbH, Robert Koch Strasse 1, D-22851 Norderstedt, Germany / 1.  VICRYL Polyglactin 910 Violet Dyed and Undyed Synthetic Absorbable Sutures
2.  VICRYL Plus Suture with Triclosan
3.  VICRYL Rapide Polyglactin 910 Violet Dyed & Undyed Synthetic Absorbable Sutures
4.  PROLENE monofilament Polypropylele Blue Dyed & Undyed Synthetic non-absorbable sutures / 31-816 (FF-319)-MD/08-DC (Re-Reg. 2011) / MD-816 (FF-319) / 14-02-2014
24. / M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036 / M/s. Medinol Limited, PO Box 45026, Back Tech Bldg, 4th Floor, Har-Hotzvim B, Hartom Street 8, Jerusalem 91450, Israel / PRESILLION Plus CoCr Coronary Stent on RX System (Sterile) (PRESILLION Plus Stent System) / 31-788-MD/2010-DC / MD-788 / 14-02-2014
25. / M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036 / M/s. Cordis Corporation, 14201, North West 60th Avenue, Miami Lakes, Florida 33014, USA having factory premises at M/s. Lake Region Medical, 340 lake Hazeltine Drive Chaska, MN 55318, USA / Emboli Capture Guidewire System: Angioguard XP and Angioguard RX / 31-859A-MD/2010-DC / MD-859A / 31-01-2014
26. / M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036 / M/s. Codman & Shurtleff Inc, 325 Paramount Drive Raynham, Massachusetts, USA / Duraform Dual Graft Implant (Absorbable collagen-Sterile) / 31-815 (A)- (FF-321)-MD/2008-DC (Re-Reg. 2010) / MD-815 (A) (FF-321) / 31-03-2014
27. / M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093 / M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s. Medtronic Ireland parkmore Business park, West Galway, Ireland / 1.  Endeavor Zotarolimus Eluting Coronary Stent System
2.  Endeavor-Sprint-Zotarolimus-Eluting RX Coronary Stent System
3.  Endeavor Resolute Zotarolimus Eluting Coronary Stent System
4.  Assurant Cobalt Over-The wire lilac Stent System / 31-64-MD/2006-DC (Re-Reg. 2009) / MD-64 / 31-07-2012
28. / M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093 / M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s. Medtronic Ireland parkmore Business park, West Galway, Ireland / 1.  Talent Abdominal/AUI Stent graft with Xcelerant Hydro Delivery System
2.  Valiant Stent Graft with Xcelerant Delivery System / 31-64-MD/2006-DC (Re-Reg. 2009) (PT-IV) / MD-64 / 31-07-2012
29. / M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093 / M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s. Medtronic Vascular 37A, Cherry Hill Drive, Danvers, MA 09123, USA / 1.  Launcher Guide Catheter
2.  Vascular Diagnostic Catheter (a) SiteSeer
(b) ProFlow
3. PTCA Guidewires
4. Angiographic Guidewires
5. Export and Export XT Aspiration Catheters
6. Guardwire Occlusion and Aspiration System
7. Woven Angiographic Catheters
8. Sherpa NX Guiding Catheters / 31-63-MD/2006-DC (Re-Reg. 2009) / MD-63 / 31-08-2012
30. / M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093 / M/s. Medtronic Sofamore Danek USA Inc, 1800 Pyramid Place, Memphis, TN 38132, USA having factory premises at M/s. Medtronic Sofamore Danek Manufacturing 2500, Silveus Crossing Waresaw, Indiana, USA 46582 / 1.  Atlas Cable System
2.  Brayan Cervical Disc System
3.  MAV Motion Segment Replacement-A-MAV & O-MAV Artificial Disc Replacement
4.  LT-CAGE Lumber Tapered Fusion Device
5.  Prestige LP Cervical Disc System
6.  ATLANTIS Anterior Cervical Plate System
7.  BASIS Spinal System
8.  CD HORIZON Spinal System
9.  Pyramesh C Mesh
10.  Pyramesh Implant System
11.  Vertek Reconstruction Implants
12.  Zephir Anterior Cervical Plate System
13.  Dynamic Compression SMA Stapple System
14.  TSRH Spinal System
15.  UCSS Universal Cannulated Cortical Bone Screw
16.  Colorado 2 Spinal System / 31-69-MD/2006-DC (Re-reg. 2009) / MD-69 / 31-01-2013
31. / M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093 / M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s. C.R. Bard Inc, 289 Bay Road, Queensbury, NY 12804, USA / Rashkind Septostomy Catheter / 31-341-MD/2007-DC (Re-Reg. 2010) / MD-341 / 14-08-2013
32. / M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093 / M/s. Medtronic Sofamore Danek USA Inc, 1800 Pyramid Place, Memphis, TN 38132, USA having factory premises at M/s. Medtronic Sofamore Danek USA Inc, 4340 Swinnea Road, Memphis TN 38118 / Infuse Bone Graft / 31-69B-MD/2006-DC (Re-Reg. 2009) / MD-69B / 14-04-2013
33. / M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093 / M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s. Medtronic vascular, 37A, Cherry Hill Drivew, Danvers, MA 09123, USA / Total 5 Products / 31-63-MD/2006-DC (Re-Reg. 2009) (End 01) / MD-63 / 31-08-2012
34. / M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093 / M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s Medtronic Ireland parkmore Business Park West Galway, Ireland / Sprinter Legend Over the Wire Balloon Dilatation Catheter / 31-64-MD/2006-DC (Re-Reg. 2009) (PT-V) / MD-64 / 31-07-2012
35. / M/s. Allergan Healthcare India Private Limited, Level 2, Presige Obelisk, No. 3 Kasturba Road, Bangalore-560001 / M/s. Allergan, 31, rue des Colonnes du Trone, 75012, Paris, France having factory premises at M/s. Allergan Route de promery, Zone Artisanale de pre-Mairy, 74370 Pringy, France / Hyaluronic Acid with Lidocaine / 31-483-MD/2008-DC (End 01) / MD-483 / 31-05-2012