FDA Registration
Active
🇩🇪 Germany
USHIO GERMANY GmbH
Reg #: 8010905
·
FEI: 3425
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- USHIO GERMANY GmbH
- Registration Number
- 8010905
- FEI Number
- 3425
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Muenchener Strasse 10
- City
- Steinhoering Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K152095
Owner / Operator
- Firm Name
- USHIO GERMANY GmbH
- Operator Number
- 10028997
- Address
- Muenchener Strasse 10
- City
- Steinhoering
- State
- Bavaria
- Postal Code
- 85643
- Country
- DE
- Correspondent
- Heinz-Juergen Wesseling
US Agent
- Business Name
- Ushio America Inc.
- Contact Name
- Michelle Robertson
- Address
- 5440 Cerritos Avenue, 5440 Cerritos Avenue
- City
- Cypress
- State
- CA
- ZIP
- 90630
- Country
- US
- [email protected]
- Phone
- 714 2293133
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Booth, Sun Tan | LEJ | Class 2 | General, Plastic Surgery | No | 2020-02-26 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device