Edwards Commander M Delivery system
by Edwards Lifesciences LLC United States EUDAMED
Ref 9880CM29CE
EMDN P07038002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0690103D003CM3000M7 | Date2 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- G70 039555 0224 Supplemented
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 16 Jun 2026
- Expires
- 10 Apr 2030
- Reason
- Add device or group
Specification
- Model / Reference
- 9880CM29CE
- Primary DI / UDI-DI
- 00690103218121
- Basic UDI-DI
- 0690103D003CM3000M7
- EMDN Code
- P07038002 Cardiac valve transcatheter implant accessories
- 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 (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 00690103218121|0690103D003CM3000M7