ALLEGRA Transcatheter Heart Valve
Ref THV-AO0027G1REModel ALLEGRA THV
Expiring
CE MDR
Valid until
28 Jul 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number51380-60-04-00 | Date1 Aug 2025 | StatusActive |
Certificates
- 51380-60-04-00 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification GmbH 0124
- Issued
- 1 Aug 2025
- Expires
- 20 Sep 2030
- Valid from
- 21 Sep 2025
- 51380-61-B0-01 Expiring
Technical documentation EU MDR
- Certifier
- DEKRA Certification GmbH 0124
- Issued
- 25 Mar 2025
- Expires
- 28 Jul 2027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Device Name
- ALLEGRA Transcatheter Heart Valve (THV)
- Model / Reference
- ALLEGRA THV, THV-AO0027G1RE
- Primary DI / UDI-DI
- 04260508661028
- Basic UDI-DI
- 426050866THVAOXXXXG1REAC
- EMDN Code
- P070301030201 Stented biological aortic valves for percutaneous implant - non-valve tissue of animal origin
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005426
Other devices from NVT GmbH
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No