Low Profile Neuro Plates, Mesh Plates and Burr Hole Covers
Ref 421.541Model Low Profile Neuro Plates, Mesh Plates and Burr Hole Covers
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 | Number7611819a00676KF 07611819753846 | 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- Withdrawn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
- Low Profile Neuro Plates, Mesh Plates and Burr Hole Covers
- Model / Reference
- Low Profile Neuro Plates, Mesh Plates and Burr Hole Covers, 421.541
- Primary DI / UDI-DI
- 07611819753846
- Basic UDI-DI
- 7611819a00676KF
- EMDN Code
- P09120599 Bone fixation plates - other
- Device Class
- Class IIb
- 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 (12)
- Sterile: 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