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MR-IM Femoral End Cap for Lag Screw
EUDAMEDClass IIb (EU MDR)
Ref F14FB-PA00582Ref F14FB-PA00579Ref F14FB-PA00580Ref F14FB-PA00581
Identity
- Trade Name
- MR-IM Femoral End Cap for Lag Screw EUDAMED
- Device Name
- Non-sterile Intramedullary Nailing Systems EUDAMED
- Model / Reference
- F14FB-PA00582 EUDAMEDF14FB-PA00579 EUDAMEDF14FB-PA00580 EUDAMEDF14FB-PA00581 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934635754165 EUDAMED06934635754196 EUDAMED06934635754189 EUDAMED06934635754172 EUDAMED
- Basic UDI-DI
- B-06934635754165 EUDAMEDB-06934635754196 EUDAMEDB-06934635754189 EUDAMEDB-06934635754172 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
MR-IM Femoral End Cap for Lag 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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- 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-06934635754165 | 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 (4)
- EUDAMED 73649ee0-e0e8-48b7-b2c3-bd780aadfa0a 61 fields · synced Oct 6, 2026
- EUDAMED 37c60ee1-af9c-407c-bfe0-db1b885acc84 61 fields · synced May 17, 2026
- EUDAMED e1f17e2f-90b2-4293-9343-3fa7a290f7b9 61 fields · synced May 18, 2026
- EUDAMED 5f578992-7463-460d-baf1-4ea911e582bd 61 fields · synced May 18, 2026