FDA Registration
Active
🇳🇱 Netherlands
AMO GRONINGEN BV
Reg #: 9614546
·
FEI: 3004651700
·
Expires 2026
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- AMO GRONINGEN BV
- Registration Number
- 9614546
- FEI Number
- 3004651700
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Van Swietenlaan 5
- City
- GRONINGEN
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K191949
- PMA Number
- P980040
Owner / Operator
- Firm Name
- Johnson & Johnson Surgical Vision, Inc.
- Operator Number
- 10053607
- Address
- 31 Technology Dr., Suite 200
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Rosanne Melikian
US Agent
- Business Name
- Johnson & Johnson Vision
- Contact Name
- Rosanne Melikian
- Address
- 31 Technology Dr., Suite 200
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 714 3138856
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2019-10-17 |
| Implant, Eye Valve | KYF | Class 2 | Ophthalmic | No | 2016-12-22 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2016-12-22 |
| Extended Depth Of Focus Intraocular Lens | POE | Class 3 | Ophthalmic | No | 2016-12-22 |
| Lens, Intraocular, Toric Optics | MJP | Class 3 | Ophthalmic | No | 2016-12-22 |
| Lens, Multifocal Intraocular | MFK | Class 3 | Ophthalmic | No | 2016-12-22 |
Proprietary Names
IMPLANT, EYE VALVE
LENS, MULTIFOCAL INTRAOCULAR
Establishment Types
Manufacture Medical Device