External orthopaedic fixation system component single use
Ref 03.311.213Model External orthopaedic fixation system component single use
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00013HR 07611819411494 | Date8 Sep 2025 | StatusActive |
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- Withdrawn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 Active
Specification
- Device Name
- External orthopaedic fixation system component single use
- Model / Reference
- External orthopaedic fixation system component single use, 03.311.213
- Primary DI / UDI-DI
- 07611819411494
- Basic UDI-DI
- 7611819a00013HR
- EMDN Code
- P0912040102 Axial bone fixation systems
- 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