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Splint
EUDAMEDClass I (EU MDR)
Ref YXH-10Model 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 EUDAMEDYXH-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974580871197 EUDAMED
- Basic UDI-DI
- 6974580870003DS EUDAMED
- EMDN Code
- Y060680 UPPER LIMB ORTHOSES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 — CE/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 fab32b4e-019b-4929-92dc-b129fc24cc0c 61 fields · synced Oct 7, 2026