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Splint
EUDAMEDClass I (EU MDR)
Ref XH-15AModel YXH-12,YXH-8D,YXH-9,YXH-10,YXH-8B,YXH-9A,YXH-9B,XH-15A,XH-15B,XH-15C,MALLEBLE SPLINT
by Zhangjiagang Xiehe Medical Apparatus&Instruments Co., Ltd.
Identity
- Device Name
- Splint EUDAMED
- Model / Reference
- YXH-12,YXH-8D,YXH-9,YXH-10,YXH-8B,YXH-9A,YXH-9B,XH-15A,XH-15B,XH-15C,MALLEBLE SPLINT EUDAMEDXH-15A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974580875508 EUDAMED
- Basic UDI-DI
- 6974580870003DS EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Splint by Zhangjiagang Xiehe Medical Apparatus&Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6974580870003DS | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000008449
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 34fe4380-d79e-4109-92fd-4bf6813d8dc3 61 fields · synced Jun 17, 2026