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Splint
EUDAMEDClass I (EU MDR)
Ref XH-15A-92Model 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-92 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974580877229 EUDAMED
- Basic UDI-DI
- 6974580870003DS EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Category: Hand/finger splint, reusable
Splint by Zhangjiagang Xiehe Medical Apparatus&Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
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 bb765679-e6ba-46d9-923e-9a4e9b746c17 61 fields · synced Jun 19, 2026