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Low Profile Neuro Plates, Mesh Plates and Burr Hole Covers
EUDAMEDClass IIb (EU MDR)
Ref 421.544Model Low Profile Neuro Plates, Mesh Plates and Burr Hole Covers
by Synthes GmbH
Identity
- Device Name
- Low Profile Neuro Plates, Mesh Plates and Burr Hole Covers EUDAMED
- Model / Reference
- Low Profile Neuro Plates, Mesh Plates and Burr Hole Covers EUDAMED421.544 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819753877 EUDAMED
- Basic UDI-DI
- 7611819a00676KF EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic fixation plate, non-bioabsorbable
Low Profile Neuro Plates, Mesh Plates and Burr Hole Covers by Synthes GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7611819a00676KF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (1)
- EUDAMED 2b16aebf-3405-493d-9fe1-b46b5a65966a 61 fields · synced Jun 18, 2026