FDA Registration
Active
🇬🇧 United Kingdom
BIOFINITY; BIOFINITY MULTIFOCAL; BIOFINITY TORIC
Reg #: 3013124682
·
FEI: 3013124682
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GO PRO NOW LTD
- Registration Number
- 3013124682
- FEI Number
- 3013124682
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11 - 12 The Courtyard, St Marys Chare
- City
- Hexham Northumberland
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K052560
Owner / Operator
- Firm Name
- Go Pro Now Ltd
- Operator Number
- 10056523
- Address
- Business Centre, 43 Yaverland Drive
- City
- Bagshot
- State
- Surrey
- Postal Code
- GU19 5DX
- Country
- GB
- Correspondent
- James Weston Weston
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2019-06-21 |
Proprietary Names
BIOFINITY; BIOFINITY MULTIFOCAL; BIOFINITY TORIC
Establishment Types
Export Device to the United States But Perform No Other Operation on Device