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Check company, site and product certificates - Validation and Verification, UK and global companies
Certificate number:
MD 670368
Scope: The design and development of devices in the areas of Cardiovascular (including Cardiovascular Interventions), Peripheral (including Peripheral Interventions), Gynecology, Urology and Endoscopy, Neurology (including Neurovascular) and electrosurgical applications (including Electrophysiology) Radiology, Biliary. These products include Introducer sheath and kits, Vascular access catheter, microcatheters, Guide wires, Hemostasis devices, Thrombus catheter devices, Percutaneous access needles, Biopsy Cap and Locking Devices, Micro and Angled Support Catheters, Electrosurgical instruments & generators and device software. Design and development of external instrumentation for implantable cardiac monitors, implantable cardiac pulse generators and implantable cardioverter defibrillators including implantable cardiac pacing and defibrillation leads.
Standard/Scheme number or name | Start Date | Expiry Date |
---|---|---|
ISO 13485: 2016 | 2017-05-08 | 2026-09-01 |
Certificate number:
MDSAP 672104
Scope: The design and development of devices in the areas of Cardiovascular (including Cardiovascular Interventions), Peripheral (including Peripheral Interventions), Gynecology, Urology and Endoscopy, Neurology (including Neurovascular) and Electrosurgical applications (including Electrophysiology) Radiology, Biliary. These products include Introducer sheath and kits, Vascular access catheter, Microcatheters, Guide wires, Hemostasis devices, Thrombus catheter devices, Percutaneous access needles, Electrosurgical instruments & generators and device software, Biopsy Cap and Locking Devices, Micro and Angled Support Catheters product families.
Design and Development of external instrumentation for implantable cardiac monitors, implantable cardiac pulse generators and implantable cardioverter defibrillators including implantable cardiac pacing and defibrillation leads.
Standard/Scheme number or name | Start Date | Expiry Date |
---|---|---|
MDSAP | 2018-02-21 | 2026-09-01 |
Site Name | Site Address | Certificate/License number | Standard/Scheme number or name |
---|---|---|---|
Boston Scientific Corporation |
302 Parkway Global Park Heredia Costa Rica |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
2546 First Street, Propark El Coyol, Alajuela Costa Rica |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
300 Boston Scientific Way Marlborough USA |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
780 Brookside Drive Spencer USA |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Ltd. |
2 Paget Rd Unit #2 Brampton Canada |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
100 Boston Scientific Way Marlborough USA |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
4100 Hamline Ave. N. St. Paul USA |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Medical Device (Malaysia) SDN BHD |
PMT 741, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan, 14110 Bandar Cassia, Pulau Pinang Malaysia |
MD 670368 | ISO 13485: 2016 |
BSC Medical Device Technology (Shanghai) Co., Ltd. |
Unit 3005, Hong Kong Prosperity Tower No. 763 Mengzi Road Huangpu District Shanghai China |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
10700 Bren Road West Minnetonka USA |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Limited |
Cashel Road Clonmel Co.Tipperary Ireland |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Technology & Engineering Services Pvt. Ltd. |
Cummins India Office Campus 5th Floor, Tower-B, Survey No. 21, Baner Balewadi Road Balewadi Pune India |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Puerto Rico LLC |
No. 12, Road 698 Dorado Puerto Rico |
MD 670368 | ISO 13485: 2016 |
Boston Scientific International Sdn. Bhd |
PMT 741 Persiaran Cassia Selatan 1 Taman Perindustrian Batu Kawan Bandar Cassia Malaysia |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
10700 Xylon Avenue North Brooklyn Park USA |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
11480 Lakefield Drive Johns Creek USA |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
309 Waverley Oaks Rd Waltham USA |
MD 670368 | ISO 13485: 2016 |
Boston Scientific Corporation |
302 Parkway Global Park Heredia Costa Rica |
MDSAP 672104 | MDSAP |
Boston Scientific Corporation |
2546 First Street, Propark El Coyol, Alajuela Costa Rica |
MDSAP 672104 | MDSAP |
Boston Scientific Corporation |
300 Boston Scientific Way Marlborough USA |
MDSAP 672104 | MDSAP |
Boston Scientific Corporation |
780 Brookside Drive Spencer USA |
MDSAP 672104 | MDSAP |
Boston Scientific Ltd. |
2 Paget Rd Unit #2 Brampton Canada |
MDSAP 672104 | MDSAP |
Boston Scientific Corporation |
100 Boston Scientific Way Marlborough USA |
MDSAP 672104 | MDSAP |
Boston Scientific Corporation |
4100 Hamline Ave. N. St. Paul USA |
MDSAP 672104 | MDSAP |
Boston Scientific Medical Device (Malaysia) SDN BHD |
PMT 741, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan, 14110 Bandar Cassia, Pulau Pinang Malaysia |
MDSAP 672104 | MDSAP |
BSC Medical Device Technology (Shanghai) Co., Ltd. |
Unit 3005, Hong Kong Prosperity Tower No. 763 Mengzi Road Huangpu District Shanghai China |
MDSAP 672104 | MDSAP |
Boston Scientific Corporation |
10700 Bren Road West Minnetonka USA |
MDSAP 672104 | MDSAP |
Boston Scientific Limited |
Cashel Road Clonmel Co.Tipperary Ireland |
MDSAP 672104 | MDSAP |
Boston Scientific Technology & Engineering Services Pvt. Ltd. |
Cummins India Office Campus 5th Floor, Tower-B, Survey No. 21, Baner Balewadi Road Balewadi Pune India |
MDSAP 672104 | MDSAP |
Boston Scientific Puerto Rico LLC |
No. 12, Road 698 Dorado Puerto Rico |
MDSAP 672104 | MDSAP |
Boston Scientific International Sdn. Bhd |
PMT 741 Persiaran Cassia Selatan 1 Taman Perindustrian Batu Kawan Bandar Cassia Malaysia |
MDSAP 672104 | MDSAP |
Boston Scientific Corporation |
10700 Xylon Avenue North Brooklyn Park USA |
MDSAP 672104 | MDSAP |
Boston Scientific Corporation |
11480 Lakefield Drive Johns Creek USA |
MDSAP 672104 | MDSAP |
Boston Scientific Corporation |
309 Waverley Oaks Rd Waltham USA |
MDSAP 672104 | MDSAP |