FDA Registration
Active
🇩🇪 Germany
DRAPES Sterile
Reg #: 9615010
·
FEI: 3003481798
·
Expires 2025
Products
1
Proprietary Names
12
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 |
|---|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-10-10 |
Proprietary Names
DRAPES Sterile
OPMI Drape Sterile
OPMI Drape
Drapes
VisionGuard Replacement Lenses
Foot Switch Drapes
VisionGuard Lens Protectors
INTRABEAM Drape
Asepsis Caps
SMARTDRAPE
SMARTDRAPE Replacement Lenses
INTRABEAM SMARTDRAPE
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device