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4.5 mm Tibial Locking Screw
EUDAMEDClass IIb (EU MDR)
Ref F14FB-PA00280Ref F14FB-PA00282Ref F14FB-PA00284Ref F14FB-PA00279Ref F14FB-PA00285Ref F14FB-PA00286
Identity
- Trade Name
- 4.5 mm Tibial Locking Screw EUDAMED
- Device Name
- Non-sterile Intramedullary Nailing Systems EUDAMED
- Model / Reference
- F14FB-PA00280 EUDAMEDF14FB-PA00282 EUDAMEDF14FB-PA00284 EUDAMEDF14FB-PA00279 EUDAMEDF14FB-PA00285 EUDAMEDF14FB-PA00286 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943242375830 EUDAMED06943242375854 EUDAMED06943242375878 EUDAMED06943242375823 EUDAMED06943242375885 EUDAMED06943242375892 EUDAMED
- Basic UDI-DI
- B-06943242375830 EUDAMEDB-06943242375854 EUDAMEDB-06943242375878 EUDAMEDB-06943242375823 EUDAMEDB-06943242375885 EUDAMEDB-06943242375892 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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
Category: Arthrodesis intramedullary nail, non-distracting
4.5 mm Tibial Locking Screw by Wuhan Mindray Scientific Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
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- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
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-06943242375830 | 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 (6)
- EUDAMED 9333ab71-d520-451c-b5a7-ab95566e55d2 61 fields · synced Jul 15, 2026
- EUDAMED cfa2dd9d-792f-459f-8a4f-945ff5040cd6 61 fields · synced May 17, 2026
- EUDAMED 841e9b94-73df-4902-a88c-8bd7a18d39bd 61 fields · synced May 17, 2026
- EUDAMED 9e9d4b66-69ee-4a54-bce7-31464620293a 61 fields · synced May 18, 2026
- EUDAMED 9b340bc3-1c40-400f-a932-e8debc337925 61 fields · synced May 18, 2026
- EUDAMED 34455e6e-456c-43fb-a429-eb60da6c308f 61 fields · synced May 19, 2026