Tfn-Advanced
Ref 60.045.016, 68.045.014, 60.045.012, 60.045.013, 03.037.025, 60.037.022, 60.037.023, 68.045.012, 68.037.002, 04.038.180S, 60.045.014, 60.037.005, 60.037.024, 04.038.175S, 60.037.012, 60.037.021, 60.037.020, 60.037.007, 04.038.170S, 60.037.011, 68.037.005, 60.037.006, 04.038.230S, 04.038.185S, 68.045.013, 04.038.220S, 04.038.210S, 03.037.022SModel Cases for Trauma/ CMF Devices, Orthopaedic Insertion and Extraction Instruments, TFNA screw, Reamers Power driven
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 | Number7611819a00012HP | Date6 Nov 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- Withdrawn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
- Cases for Trauma/ CMF DevicesOrthopaedic Insertion and Extraction InstrumentsTFNA screwReamers Power driven
- Model / Reference
- Cases for Trauma/ CMF Devices, 60.045.016, 68.045.014, 60.045.012, 60.045.013, Orthopaedic Insertion and Extraction Instruments, 03.037.025, 60.037.022, 60.037.023, 68.045.012, 68.037.002, TFNA screw, 04.038.180S, 60.045.014, 60.037.005, 60.037.024, 04.038.175S, 60.037.012, 60.037.021, 60.037.020, 60.037.007, 04.038.170S, 60.037.011, 68.037.005, 60.037.006, 04.038.230S, 04.038.185S, 68.045.013, 04.038.220S, 04.038.210S, Reamers Power driven, 03.037.022S
- Primary DI / UDI-DI
- 07612334213167, 07612334184771, 07612334184559, 07612334184566, 07611819642515, 07611819676107, 07611819676114, 07612334184757, 07611819644151, 07611819652293, 07612334184573, 07611819676039, 07611819676121, 07611819652286, 07611819676077, 07611819676091, 07611819676084, 07611819676053, 07611819652279, 07611819676060, 07611819644182, 07611819676046, 07611819652392, 07611819652309, 07612334184764, 07611819652378, 07611819652354, 07611819618626
- Basic UDI-DI
- 7611819a00012HP, 7611819a00219JF, 7611819a00768KM, 7611819a00574K6
- Direct Marketing DI
- 0761233421316707612334184771076123341845590761233418456607611819642515076118196761070761181967611407612334184757076118196441510761233418457307611819676039076118196761210761181967607707611819676091076118196760840761181967605307611819644182076118196760460761233418476407611819642485
- EMDN Code
- Z12011399, L091001, P09120601, Z12130599
- Device Class
- Class IClass IIbClass IIa
- 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 (9)
- 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