FDA Registration
Active
🇬🇧 United Kingdom
Biofinity
Reg #: 3006514242
·
FEI: 3006514242
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CooperVision Manufacturing Ltd
- Registration Number
- 3006514242
- FEI Number
- 3006514242
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Delta Park, Concorde Way, Segensworth North
- City
- Fareham Hampshire
- Country
- GB
Regulatory Submissions
- PMA Number
- P080011
Owner / Operator
- Firm Name
- COOPERVISION, INC.
- Operator Number
- 9929062
- Address
- 6101 Bollinger Canyon Road, Suite 500
- City
- San Ramon
- State
- CA
- Postal Code
- 94583
- Country
- US
US Agent
- Business Name
- COOPERVISION, INC.
- Contact Name
- ANNETTE NELSON
- Address
- 6101 Bollinger Canyon Road, Suite 500
- City
- San Ramon
- State
- CA
- ZIP
- 94583
- Country
- US
- [email protected]
- Phone
- 925 6604471
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lenses, Soft Contact, Extended Wear | LPM | Class 3 | Ophthalmic | No | 2008-12-23 |
Proprietary Names
Biofinity
BIOFINITY MULTIFOCAL
BIOFINITY TORIC
BIOFINITY XR
Biofinity Energys
Biofinity XR Multifocal
BIOFINITY TORIC MULTIFOCAL
Biofinity XR Toric
Establishment Types
Export Device to the United States But Perform No Other Operation on Device