FDA Registration
Active
🇩🇪 Germany
Papyrus
Reg #: 3011574793
·
FEI: 3011574793
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CORTRONIK GmbH
- Registration Number
- 3011574793
- FEI Number
- 3011574793
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Friedrich-Barnewitz-Str. 4a
- City
- Rostock-Warnemuende Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- PMA Number
- H170004
Owner / Operator
- Firm Name
- BIOTRONIK AG
- Operator Number
- 10024585
- Address
- Ackerstrasse 6
- City
- Buelach
- State
- Zurich
- Postal Code
- CH-8180
- Country
- CH
US Agent
- Business Name
- BIOTRONIK, INC.
- Contact Name
- Jon Brumbaugh
- Address
- 6024 JEAN RD
- City
- Lake Oswego
- State
- OR
- ZIP
- 97035
- Country
- US
- [email protected]
- Phone
- 503 4518310
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronary Covered Stent | NIV | Class f | Unknown | No | 2018-12-26 |
Proprietary Names
Papyrus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)