FDA Registration
Active
🇩🇪 Germany
RIWO D-URS
Reg #: 3003923762
·
FEI: 3003923762
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSYPKA AG
- Registration Number
- 3003923762
- FEI Number
- 3003923762
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Earl-H.-Wood-Str. 1
- City
- Rheinfelden Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K201897
Owner / Operator
- Firm Name
- Osypka AG
- Operator Number
- 10048738
- Address
- Earl-H.-Wood-Str. 1
- City
- Rheinfelden
- State
- Baden-Wurttemberg
- Postal Code
- 79618
- Country
- DE
- Correspondent
- Nicola Osypka
US Agent
- Business Name
- Alan VanHouten Biomedical Consulting
- Contact Name
- Alan VanHouten
- Address
- 916 Ridgecrest Drive
- City
- Carver
- State
- MN
- ZIP
- 55315
- Country
- US
- [email protected]
- Phone
- 952 3932987
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2022-08-21 |
Proprietary Names
RIWO D-URS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)