Expert
Ref 68.004.022Model Cases for Trauma/ CMF Devices
Withdrawn
CE MDR, withdrawn
Ended
Withdrawn
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00012HP 07611819824003 | Date6 Nov 2025 | StatusWithdrawn |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Device Name
- Cases for Trauma/ CMF Devices
- Model / Reference
- Cases for Trauma/ CMF Devices, 68.004.022
- Primary DI / UDI-DI
- 07611819824003
- Basic UDI-DI
- 7611819a00012HP
- Direct Marketing DI
- 07611819824003
- EMDN Code
- Z12011399 Cleaning, disinfection and sterilisation instruments - other
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CH-MF-000013345
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Synthes GmbH
Properties
Other properties (13)
- Sterile: No
- 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