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Straight Plate (I)
EUDAMEDClass IIb (EU MDR)
Ref F14HB-PA00048Ref F14HB-PA00044Ref F14HB-PA00046
Identity
- Trade Name
- Straight Plate (I) EUDAMED
- Device Name
- Non-sterile Bone Plates EUDAMED
- Model / Reference
- F14HB-PA00048 EUDAMEDF14HB-PA00044 EUDAMEDF14HB-PA00046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943242365534 EUDAMED06943242365497 EUDAMED06943242365510 EUDAMED
- Basic UDI-DI
- B-06943242365534 EUDAMEDB-06943242365497 EUDAMEDB-06943242365510 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
Straight Plate (I) 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-06943242365534 | 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 (3)
- EUDAMED c16a3fd4-fa0c-4b4c-8e32-6ed55d5b269d 61 fields · synced Jul 30, 2026
- EUDAMED 768271b5-6d89-489d-8301-4c66809d8792 61 fields · synced May 17, 2026
- EUDAMED 50e9db72-1c0f-4571-bc44-4ff949ebeb55 61 fields · synced May 18, 2026