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Splint Kit
EUDAMEDClass I (EU MDR)
Ref 5971Model Schiene 95x45mm 230x110mm 457x110mm 914x110mm
Identity
- Trade Name
- Splint Kit EUDAMED
- Device Name
- Splint Roll EUDAMED
- Model / Reference
- Schiene 95x45mm 230x110mm 457x110mm 914x110mm EUDAMED5971 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942013210776 EUDAMED
- Basic UDI-DI
- 697023378SplintRollNSTB2 EUDAMED
- Direct Marketing DI
- 06942013210776 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hand/finger splint, reusable
Splint Kit by Hubei V-Medical Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697023378SplintRollNSTB2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei V-Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000011268
- Authorised Representative
- RAFFIN MEDICAL FR-AR-000004632
Sources (1)
- EUDAMED 8788a049-91e9-4e70-ac2f-5fdd40b52f34 61 fields · synced Jun 18, 2026