FDA Registration
Active
🇲🇾 Malaysia
Boston Scientific Medical Device (Malaysia) SDN BHD
Reg #: 3014222368
·
FEI: 3014222368
·
Expires 2026
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Boston Scientific Medical Device (Malaysia) SDN BHD
- Registration Number
- 3014222368
- FEI Number
- 3014222368
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PMT 741, Persiaran Cassia Selatan 1, Bandar Cassia
- City
- Taman Perindustrian Batu Kawan Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K220629
Owner / Operator
- Firm Name
- Boston Scientific Corporation
- Operator Number
- 9912058
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
US Agent
- Business Name
- BOSTON SCIENTIFIC CORPORATION
- Contact Name
- Aaron Dunbar
- Address
- 300 BOSTON SCIENTIFIC WAY
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
- [email protected]
- Phone
- 651 3961414
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2022-03-29 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2018-05-11 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2014-09-05 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-08-21 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2014-09-05 |
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | Class 2 | Gastroenterology, Urology | No | 2022-05-12 |
Establishment Types
Manufacture Medical Device