SAPIEN M3 RESILIA Transcatheter Heart Valve
Ref 9890RSL29CE
Active
CE MDR
Valid until
10 Apr 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0690103D004SM3000U8 00690103222166 | Date2 Sep 2026 | StatusActive |
Certificates
- G70 039555 0224 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 16 Jun 2026
- Expires
- 10 Apr 2030
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SAPIEN M3 RESILIA Valve
- Model / Reference
- 9890RSL29CE
- Primary DI / UDI-DI
- 00690103222166
- Basic UDI-DI
- 0690103D004SM3000U8
- EMDN Code
- P070301030202 Stented biological mitral valves for percutaneous implant - non-valve tissue of animal origin
- Device Class
- Class III
- EU 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
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No