FDA Registration
Active
🇩🇪 Germany
S100 / OPMI pico i
Reg #: 9615010
·
FEI: 3003481798
·
Expires 2025
Products
1
Proprietary Names
24
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CARL ZEISS MEDITEC AG (OBERKOCHEN)
- Registration Number
- 9615010
- FEI Number
- 3003481798
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- RUDOLF-EBER-STRASSE 11
- City
- OBERKOCHEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- Carl Zeiss Meditec, Inc.
- Operator Number
- 9053564
- Address
- 5300 Central Parkway
- City
- Dublin
- State
- CA
- Postal Code
- 94568
- Country
- US
- Correspondent
- Paul Swift
US Agent
- Business Name
- CARL ZEISS MEDITEC USA, INC.
- Contact Name
- Paul Swift
- Address
- 5300 Central Parkway
- City
- Dublin
- State
- CA
- ZIP
- 94568
- Country
- US
- [email protected]
- Phone
- 817 9258507
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2011-12-08 |
Proprietary Names
S100 / OPMI pico i
S88 / OPMI Lumera T
S8/OPMI VISU 200
OPMI Lumera 700
S8 / OPMI Lumera T
S81 / OPMI Lumera T
S7 / OPMI Lumera
RESIGHT 700 (with accessories)
RESIGHT 500 (with acccessories)
S7 / OPMI VISU 140
S7 / OPMI VISU 160
OPMI 1 FR pro
S8/OPMI VISU 160
OPMI Lumera i
S81/OPMI VISU 160
S81/OPMI VISU 210
ARTEVO 800
UC 3D Digital Upgrade Kit
S88/OPMI VISU 160
S8/OPMI VISU 210
S88/OPMI VISU 210
ARTEVO 750/850
OPMI Lumera 300
Single-use lenses for RESIGHT
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device