FDA Registration
Active
🇬🇧 United Kingdom
CooperVision Manufacturing, LTD.
Reg #: 3008586477
·
FEI: 3008586477
·
Expires 2026
Products
4
Proprietary Names
17
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- CooperVision Manufacturing, LTD.
- Registration Number
- 3008586477
- FEI Number
- 3008586477
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Mountpark, Unit 1
- City
- Wide Lane Southampton
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K001090
- 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, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2014-09-18 |
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2019-01-18 |
| Lenses, Soft Contact, Extended Wear | LPM | Class 3 | Ophthalmic | No | 2008-12-23 |
| Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | QIT | Class 3 | Unknown | No | 2019-11-18 |
Proprietary Names
Clariti 1 Day
Clariti 1 Day Multifocal
Clariti 1 Day Toric
BIOFINITY XR
BIOFINITY MULTIFOCAL
BIOFINITY TORIC
Biofinity
Biofinity Energys
Biofinity XR Toric
Biofinity XR Multifocal
BIOFINITY TORIC MULTIFOCAL
Softmed Breathables Advanced Toric
Avaira (enfilcon A)
HYDRASOFT XW STANDARD (sphere)
HYDRASOFT TORIC XW
iWear Active
Avaira (enfilcon A) Soft Contact Lens
Establishment Types
Repack or Relabel Medical Device