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Manufacturer's licence

Register of Medical Device Manufacturer's Licence Holders

Company Name
Company Address
Licence No
3M Innovation Singapore Pte. Ltd.
2 TUAS LINK 4, SINGAPORE 637321
ES0001704
Acropolis Electronics Pte Ltd 
25 KALLANG AVENUE, #07-02, SINGAPORE 339416
ES0000378
Alphamed Pte Ltd
44 PANDAN LOOP, SINGAPORE 128260
ES0001539
Applied Biosystems B.V.
33 MARSILING IND ESTATE ROAD 3, MAPLE TREE INDUSTRIAL BUILDING, #05-03, SINGAPORE 739256
ES0000447
Aptos Threads Pte. Ltd.
583 ORCHARD ROAD, FORUM GALLERIA, #14-01, SINGAPORE 238884
ES0000208
Art Medical Devices Pte. Ltd.
30 RAFFLES PLACE, CALTEX HOUSE, #23-00, SINGAPORE 048622
ES0000284
Avalon Medical Services Pte. Ltd.
29 WOODLANDS INDUSTRIAL PARK E1, NORTHTECH, #04-13, SINGAPORE 757716
ES0000379
Baxter Healthcare SA, Singapore Branch
2 WOODLANDS INDUSTRIAL PARK D, SINGAPORE 738750
ES0000025
Becton Dickinson Critical Care Systems Pte Ltd
198 YISHUN AVENUE 7, SINGAPORE 768926
ES0000024
Becton Dickinson Medical (S) Pte Ltd
30 TUAS AVENUE 2, SINGAPORE 639461
ES0000074
Beyonics International Pte Ltd
30 MARSILING IND ESTATE ROAD 8, SINGAPORE 739193
ES0000289
Biobot Surgical Pte. Ltd.
55 AYER RAJAH CRESCENT, #06-09, SINGAPORE 139949
ES0001414
BioMers Pte Ltd
18 BOON LAY WAY, TRADEHUB 21, #05-99, SINGAPORE 609966
ES0001412
Bio-Scaffold International Pte. Ltd.
61 SCIENCE PARK ROAD, GALEN, #02-01/06, SINGAPORE 117525
ES0000364
Biosensors International Pte Ltd
21 KALLANG AVENUE, #07-165/171, SINGAPORE 339412
ES0000003
Biosensors Interventional Technologies Pte. Ltd.
10 KAKI BUKIT AVENUE 1, Kampong Ubi Industrial Estate, #06-01/04, SINGAPORE 417942
ES0000326
Cadi Scientific Pte. Ltd.
31 UBI ROAD 1, AZTECH BUILDING, #03-00, SINGAPORE 408694
ES0000358
Ciba Vision Asian Manufacturing and Logistics Pte. Ltd.
133 TUAS SOUTH AVENUE 3, SINGAPORE 637550
ES0000139
Clearlab SG Pte. Ltd.
139 JOO SENG ROAD, CLEARLAB, SINGAPORE 368362
ES0001087
Contract Sterilization Services Pte Ltd
26 AYER RAJAH CRESCENT, #05-08/09, SINGAPORE 139944
ES0000125
Crescendas Medical Corporation Pte Ltd
87 DEFU LANE 10, MEC TECHNOCENTRE, #04-00, SINGAPORE 539219
ES0000107
DHL Supply Chain Singapore Pte. Ltd.
7 CHANGI SOUTH STREET 2, XILIN DISTRICENTRE, SINGAPORE 486415
ES0001382
Dreve Singapore Pte. Ltd.
10 ANSON ROAD, INTERNATIONAL PLAZA, #09-24, SINGAPORE 079903
ES0001413
Drug Houses of Australia (Asia ) Private Limited
2 CHIA PING ROAD, HAW PAR TIGER BALM BUILDING, SINGAPORE 619968
ES0001774
Edwards Lifesciences (Singapore) Pte. Ltd.
35 CHANGI NORTH CRESCENT, SINGAPORE 499641
ES0000535
Eye-Biz Pte. Ltd.
82 GENTING LANE, MEDIA CENTRE, SINGAPORE 349567
ES0001410
First Aid Supplies Pte Ltd
1 JALAN KLEDEK, SINGAPORE 199257
ES0001384
Flextronics Manufacturing (Singapore) Pte. Ltd.
1 KALLANG PLACE, JIT ELECTRONICS BUILDING, #03-00, SINGAPORE 339211
ES0000748
Forefront Medical Technology (Pte) Ltd 
35 JOO KOON CIRCLE, SINGAPORE 629110
ES0000304
Greenleaf Medical Products Pte. Ltd.
1003 BUKIT MERAH CENTRAL, SINGAPORE 159836
ES0001537
HealthSTATS International Pte Ltd
6 NEW INDUSTRIAL ROAD, HOE HUAT INDUSTRIAL BUILDING, #04-01/02, SINGAPORE 536199
ES0000494
Hock Leng Engineering Pte. Ltd.
51 BUKIT BATOK CRESCENT, UNITY CENTRE, #07-26, SINGAPORE 658077
ES0001653
Hospimek Pte Ltd
9002 TAMPINES STREET 93, SINGAPORE 528836
ES0000891
Hoya Medical Singapore Pte. Ltd.
455A JALAN AHMAD IBRAHIM, SINGAPORE 639939
ES0001475
Inflexion Corporation Pte. Ltd.
18 NANYANG DRIVE, INNOVATION CENTRE, #02-226, SINGAPORE 637723
ES0000166
Jitron Pte. Ltd.
41 KALLANG PUDDING ROAD, #07-00F, SINGAPORE 349316
ES0001530
JMS Singapore Pte Ltd
440 ANG MO KIO INDUSTRIAL PARK 1, JMS, SINGAPORE 569620
ES0000063
Lab Rehab Pte. Ltd.
211 HOLLAND AVENUE, HOLLAND ROAD SHOPPING CENTRE, #04-03, SINGAPORE 278967
ES0000828
Leica Instruments (Singapore) Pte Limited
12 TEBAN GARDENS CRESCENT, SINGAPORE 608924
ES0000702
Lenbert Pte Ltd
13 TUAS AVENUE 12, SINGAPORE 639035
ES0000185
Masters Biotech (S) Pte Ltd
65A JALAN TENTERAM, ST. MICHAEL'S ESTATE FLATTED FACTORY, #07-13, SINGAPORE 328958
ES0000282
Medtronic Singapore Operations Pte. Ltd.
49 CHANGI SOUTH AVENUE 2, NASACO TECH CENTRE, SINGAPORE 486056
ES0001824
Menicon Singapore Pte. Ltd.
8 INTERNATIONAL BUSINESS PARK, SINGAPORE 609925
ES0000733
Merlin MD Pye. Ltd.
29 WOODLANDS INDUSTRIAL PARK E1, NORTHTECH, #04-13/14, SINGAPORE 757716
ES0000165
MI Technologies Pte. Ltd.
11 SERANGOON NORTH AVENUE 5, M.I BUILDING, #06-02, SINGAPORE 554809
ES0001765
Minntech Asia/Pacific Pte. Ltd.
1A INTERNATIONAL BUSINESS PARK, #05-01, SINGAPORE 609933
ES0001470
MP Biomedicals Asia Pacific Pte. Ltd.
2 PIONEER PLACE, MP Biomedicals Asia Pacific Pte Ltd, SINGAPORE 627885
ES0000061
Oculus Private Limited
61 TAI SENG AVENUE, UE PRINT MEDIA HUB, #05-12, SINGAPORE 534167
ES0000524
Opto-Pharm Pte Ltd
13 TUAS AVENUE 12, SINGAPORE 639035
ES0000052
Osteopore International Pte. Ltd.
10 SCIENCE PARK ROAD, ALPHA, THE, #02-28, SINGAPORE 117684
ES0000350
Puriyves Pte Ltd
3 UBI CRESCENT, YONG LEE BUILDING, #06-05, SINGAPORE 408558
ES0000105
Racer Technology Pte Ltd
28 CHANGI SOUTH STREET 1, SINGAPORE 486772
ES0001536
Resmed Asia Operations Pty Limited (Singapore Branch)
8 LOYANG CRESCENT, #08-01, SINGAPORE 509016
ES0000569
Resource Medical Pte. Ltd.
512 CHAI CHEE LANE, #06-17, SINGAPORE 469028
ES0001802
Restalyst Pte. Ltd.
3 LOYANG WAY, SINGAPORE 508719
ES0000799
Ruhlmann Pte Ltd
6 HARPER ROAD, LEONG HUAT BUILDING, #03-06, SINGAPORE 369674
ES0000181
Sanmina-Sci Systems Singapore Pte. Ltd.
2 CHAI CHEE DRIVE, ADAPTEC BUILDING, SINGAPORE 469044
ES0001538
Schon Pharmaceutical Pte Ltd
13 TUAS AVENUE 12, SINGAPORE 639035
ES0000186
Seb Pte. Ltd.
11 LOYANG LANE, SINGAPORE 508928
ES0000363
Siemens Medical Instruments Pte. Ltd.
28 AYER RAJAH CRESCENT, #06-08, SINGAPORE 139959
ES0001383
SP Manufacturing Pte. Ltd.
10 ANSON ROAD, INTERNATIONAL PLAZA, #34-18, SINGAPORE 079903
ES0000521
Steril Medical Pte Ltd
30 LOYANG WAY, LOYANG INDUSTRIAL ESTATE, #07-19-23, SINGAPORE 508769
ES0000216
Sus Treatment Pte. Ltd.
5014 ANG MO KIO AVENUE 5, #05-01, SINGAPORE 569881
ES0001626
Sys-Mac Automation Engineering Pte Ltd
2 WOODLANDS SECTOR 1, WOODLANDS SPECTRUM, #05-18, SINGAPORE 738068
ES0000820
Sysmex Asia Pacific Pte. Ltd.
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
ES0000171
Trufit Limbs Centre
112B DEPOT ROAD, DEPOT HEIGHTS, #02-129, SINGAPORE 102112
ES0000791
Unomedical (Singapore) Limited
26 AYER RAJAH CRESCENT, #04-10, SINGAPORE 139944
ES0000151
Veredus Laboratories Pte. Ltd.
83 SCIENCE PARK DRIVE, THE CURIE, #03-02A, SINGAPORE 118258
ES0001708
Vicplas Holdings Pte Ltd
35 JOO KOON CIRCLE, VICPLAS HOLDINGS, SINGAPORE 629110
ES0000229
Vitahealth Asia Pacific (S) Pte. Ltd.
371 BEACH ROAD, KEYPOINT, #02-23, SINGAPORE 199597
ES0000070
Zuellig Pharma Specialty Solutions Group Pte. Ltd.
15 CHANGI NORTH WAY, #01-01, SINGAPORE 498770
ES0000586


Manufacturer's Licence Conditions

Pursuant to section 24(5) of the Health Products Act, a manufcaturer's licence carries the following conditions:-

  1. The holder of this licence shall be permitted to supply by wholesale medical devices that have been manufactured by the holder of this licence at a facility covered under the said licence, and the said medical devices have either been registered on the Singapore Medical Device Register (SMDR), listed on the Class C and D Transition List or exempted from registration under the Health Products (Medical Devices) Regulations and section 15(1) of the Health Products Act, at the point of wholesale.
  2. The holder of this licence shall be permitted to supply by export unregistered medical devices that have been manufactured by the holder of this licence at a facility covered under the said licence, provided the medical device is labelled as follows: "This product is for export only and shall not be supplied in Singapore."
  3. The holder of this licence shall comply with all requirements under the Health Products Act and the Health Products (Medical Devices) Regulations 2010.
  4. Upon request by the Authority, the holder of this licence shall submit medical devices for batch testing in accordance to a product standard prescribed by the Authority, to a testing body recognised by the Authority as stipulated in the Health Products (Medical Devices) Regulations 2010.
  5. The holder of this licence shall be subject to a renewal fee, as stipulated in the Health Products (Medical Devices) Regulations 2010. Failure to pay the renewal fee within the allocated payment period would result in the expiry of the licence.
  6. Any changes to this licence that are reportable under Regulation 48 of the Health Products (Medical Devices) Regulations 2010, including changes to the name of the company, address and GDPMDS/ISO 13485 certification of the licencee, shall have to be notified to the Authority no later than 15 days after the date of implementation of the change. Failure to notify the Authority within 15 days would invalidate this licence with immediate effect.
  7. The holder of this licence shall not use this licence in any form of advertisement.
  8. The holder of this licence shall only be permitted to manufacture medical devices that are within the scope of the manufacturer ISO 13485 certificate that has been issued by a Certification Body (CB) recognised by the Authority.


Last updated on 01 Feb 2011 12:59:44
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