28mm Mitral Heart Valve
by HighLife France EUDAMED
Ref 631000-28 EMDN P070301030102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2292597CE01 | Date31 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 1 country, as listed in EUDAMED:
- Germany since 27 Jan 2026
Certificates
- 2292597CE01 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 31 Jul 2026
- Expires
- 1 Jan 2031
- Reason
- Add device or group
- 2292597TD01 Amended
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 31 Jul 2026
- Expires
- 1 Jan 2031
- Reason
- Other
Specification
- Model / Reference
- 631000-28
- Primary DI / UDI-DI
- 00850035587065
- Basic UDI-DI
- 0850035587631000-2879
- EMDN Code
- P070301030102 Stented biological mitral valves for percutaneous implant - valve tissue of animal origin
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- FR-MF-000015887
Other devices from HighLife
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 00850035587065|0850035587631000-2879