Identity
- Trade Name
- Mandibular Plate EUDAMED
- Device Name
- Non-sterile Bone Plates EUDAMED
- Model / Reference
- F14HB-PA00032 EUDAMEDF14HB-PA00033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943242365374 EUDAMED06943242365381 EUDAMED
- Basic UDI-DI
- B-06943242365374 EUDAMEDB-06943242365381 EUDAMED
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mandibular Plate by Wuhan Mindray Scientific Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06943242365374 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wuhan Mindray Scientific Co., Ltd.
- EUDAMED SRN
- CN-MF-000032692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED be615482-8ce3-4b7a-9e90-2db925384054 61 fields · synced Jul 14, 2026
- EUDAMED 3e8d3048-2561-4ef4-b432-f5a00a0c0a69 61 fields · synced May 17, 2026