Synthes Cutting Tools
by Synthes GmbH Switzerland EUDAMED
Ref 03.000.031 EMDN Z12130580
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00240J6 | Date30 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Cutting Tools - Burrs & Drills with a nickel diamond coating or made of tungsten carbide (Single-Use)
- Model / Reference
- 03.000.031
- Primary DI / UDI-DI
- 07611819832664
- Basic UDI-DI
- 7611819a00240J6
- EMDN Code
- Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
- Device Class
- Class IIa
- 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 & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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
Sources (1)
- EUDAMED c412cc79-aa39-4201-8fcd-ab01347e5332