FDA Registration
Active
🇨🇭 Switzerland
SimplifEYE for enVista Preloaded
Reg #: 9681862
·
FEI: 1000581837
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDICEL AG
- Registration Number
- 9681862
- FEI Number
- 1000581837
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Dornierstrasse 11
- City
- Altenrhein Sankt Gallen
- Country
- CH
Owner / Operator
- Firm Name
- MEDICEL AG
- Operator Number
- 9027853
- Address
- Dornierstrasse 11, --
- City
- Altenrhein
- State
- Sankt Gallen
- Postal Code
- 9423
- Country
- CH
- Correspondent
- Tobias - Maier
US Agent
- Business Name
- Volk Optical Inc.
- Contact Name
- Peter Chen
- Address
- 7893 Enterprise Dr.
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 9426161
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Guide, Intraocular | KYB | Class 1 | Ophthalmic | No | 2019-06-28 |
Proprietary Names
SimplifEYE for enVista Preloaded
SimplifEYE inserter for Akreos preloaded
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)