Reamer
Ref 03.628.106Model USS Fracture MIS Orthopaedic Prostheses Reamers and Burs
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00211HX 07611819475939 | Date11 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Reamer
- Model / Reference
- USS Fracture MIS Orthopaedic Prostheses Reamers and Burs, 03.628.106
- Primary DI / UDI-DI
- 07611819475939
- Basic UDI-DI
- 7611819a00211HX
- Direct Marketing DI
- 07611819475939
- EMDN Code
- L091102 Orthopaedic prostheses reamers and burs, reusable
- 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 (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No