FDA Registration
Active
🇩🇪 Germany
VISUSCOUT 100
Reg #: 9617474
·
FEI: 3002398337
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CARL ZEISS VISION GMBH
- Registration Number
- 9617474
- FEI Number
- 3002398337
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Turnstrasse 27
- City
- AALEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K132186
Owner / Operator
- Firm Name
- CARL ZEISS VISION INC.
- Operator Number
- 9072118
- Address
- 1040 Worldwide Blvd
- City
- Hebron
- State
- KY
- Postal Code
- 41048
- Country
- US
- Correspondent
- Jahmal A Cannon
US Agent
- Business Name
- Carl Zeiss Vision Inc.
- Contact Name
- Jahmal Cannon
- Address
- 1040 Worldwide Blvd
- City
- Hebron
- State
- KY
- ZIP
- 41048
- Country
- US
- [email protected]
- Phone
- 423 5982680
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2019-07-26 |
Proprietary Names
VISUSCOUT 100
Establishment Types
Export Device to the United States But Perform No Other Operation on Device