MatrixMANDIBLE
by Synthes GmbH Switzerland EUDAMED
Ref 04.497.001SModel MatrixMANDIBLE Set Screw for Condylar Head Add on
EMDN P010103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00581K3 | Date23 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- G70 056032 0143 Issued
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 20 Dec 2024
- Expires
- 19 Dec 2029
Specification
- Device Name
- MatrixMANDIBLE Set Screw for Condylar Head Add on
- Model / Reference
- MatrixMANDIBLE Set Screw for Condylar Head Add on, 04.497.001S
- Primary DI / UDI-DI
- 07611819414723
- Basic UDI-DI
- 7611819a00581K3
- EMDN Code
- P010103 Mandibular prostheses
- Device Class
- Class III
- 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 (11)
- 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 01d1712e-68fb-4bf3-84ff-c859069f9c28