Orthopaedic Torque Limiting Instruments - Power driven
by Synthes GmbH Switzerland EUDAMED
Ref 511.115Model Orthopaedic Torque Limiting Instruments - Power driven
EMDN Z12130599
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00668KG | Date30 Jul 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Orthopaedic Torque Limiting Instruments - Power driven
- Model / Reference
- Orthopaedic Torque Limiting Instruments - Power driven, 511.115
- Primary DI / UDI-DI
- 07611819254435
- Basic UDI-DI
- 7611819a00668KG
- Direct Marketing DI
- 07611819254435
- EMDN Code
- Z12130599 Motorised orthopaedic surgery system instruments - other
- 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 (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
Sources (1)
- EUDAMED faae61cb-a6ec-40d2-adf1-4bbb6af7f808