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MR-IM Spiral Blade
EUDAMEDClass IIb (EU MDR)
Ref F14FB-PA00532Ref F14FB-PA00527Ref F14FB-PA00531Ref F14FB-PA00534Ref F14FB-PA00530Ref F14FB-PA00528Ref F14FB-PA00529
Identity
- Trade Name
- MR-IM Spiral Blade EUDAMED
- Device Name
- Non-sterile Intramedullary Nailing Systems EUDAMED
- Model / Reference
- F14FB-PA00532 EUDAMEDF14FB-PA00527 EUDAMEDF14FB-PA00531 EUDAMEDF14FB-PA00534 EUDAMEDF14FB-PA00530 EUDAMEDF14FB-PA00528 EUDAMEDF14FB-PA00529 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934635754653 EUDAMED06934635754707 EUDAMED06934635754660 EUDAMED06934635754639 EUDAMED06934635754677 EUDAMED06934635754691 EUDAMED06934635754684 EUDAMED
- Basic UDI-DI
- B-06934635754653 EUDAMEDB-06934635754707 EUDAMEDB-06934635754660 EUDAMEDB-06934635754639 EUDAMEDB-06934635754677 EUDAMEDB-06934635754691 EUDAMEDB-06934635754684 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 Spiral Blade by Wuhan Mindray Scientific Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Arthrodesis intramedullary nail, non-distracting.
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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-06934635754653 | 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 (7)
- EUDAMED 48862471-54f9-4551-9ab8-743d8ef002c3 61 fields · synced Aug 4, 2026
- EUDAMED edba3b3a-3520-4320-9a8b-930adf82383c 61 fields · synced May 17, 2026
- EUDAMED 68f6f95f-2c22-4136-8b53-88338efea3b1 61 fields · synced May 18, 2026
- EUDAMED 1836edae-de66-465d-b726-3c8d7ad2d75c 61 fields · synced May 18, 2026
- EUDAMED b22e7fec-d3ad-49f7-ae13-38ba4fd2c63e 61 fields · synced May 18, 2026
- EUDAMED e60af19d-6ca0-45a2-9375-87500c3f26da 61 fields · synced May 19, 2026
- EUDAMED a4a5eca4-eb37-4ff2-860f-5744d46438e9 61 fields · synced May 19, 2026