FDA Registration
Active
🇬🇧 United Kingdom
BIOCOMPATIBLES U.K. LIMITED, a BTG Company
Reg #: 3002124543
·
FEI: 3002124543
·
Expires 2026
Products
8
Proprietary Names
1
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- BIOCOMPATIBLES U.K. LIMITED, a BTG Company
- Registration Number
- 3002124543
- FEI Number
- 3002124543
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Chapman House, Weydon Lane, Farnham Business Park
- City
- Farnham, SURREY ENGLAND
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K150876
- PMA Number
- P200029
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 |
|---|---|---|---|---|---|
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | Class 2 | Cardiovascular | No | 2019-10-10 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2019-10-10 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2019-10-10 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2023-11-15 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 1998-06-11 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2024-09-16 |
| Microspheres Radionuclide | NAW | Class 3 | Unknown | No | 2021-03-25 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2024-09-16 |
Proprietary Names
TheraSphereY-90 Glass Microspheres
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility