Edwards EVOQUE
by Edwards Lifesciences LLC United States EUDAMED
Ref 9850EV52
EMDN P070301030104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0690103D004EVV000Z3 | Date1 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 3828128TD05 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 8 Jul 2025
- Expires
- 13 Oct 2028
- Reason
- Other
Specification
- Device Name
- EVOQUE Valves
- Model / Reference
- 9850EV52
- Primary DI / UDI-DI
- 00690103212846
- Basic UDI-DI
- 0690103D004EVV000Z3
- EMDN Code
- P070301030104 Stented biological tricuspid valves for percutaneous implant - valve tissue of animal origin
- Device Class
- Class III
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000007139
- Authorised representative
- Edwards Lifesciences GmbH DE-AR-000006184
Other devices from Edwards Lifesciences LLC
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 00690103212846|0690103D004EVV000Z3