FDA Registration
Active
🇩🇪 Germany
CORTRONIK GmbH
Reg #: 3011574793
·
FEI: 3011574793
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- CORTRONIK GmbH
- Registration Number
- 3011574793
- FEI Number
- 3011574793
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Friedrich-Barnewitz-Str. 4a
- City
- Rostock-Warnemuende Mecklenburg-Western Pomerania
- Country
- DE
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
- Teleflex, Inc
- Contact Name
- Divya Raman
- Address
- 3015 Carrington Mill Boulevard
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
- [email protected]
- Phone
- 612 4231738
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stent, Coronary | MAF | Class 3 | Unknown | No | 2017-02-22 |
| Coronary Covered Stent | NIV | Class f | Unknown | No | 2018-12-26 |
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2015-12-22 |
| Stent, Superficial Femoral Artery | NIP | Class 3 | Unknown | No | 2017-03-28 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2019-02-22 |
Proprietary Names
PRO-Kinetic Energy
Papyrus
Astron
Pulsar-18
Pulsar-18 T3
Orsiro
Orsiro Mission
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)