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Hand Splint
EUDAMEDClass I (EU MDR)
Ref FS008Model FS001 FS002 FS003 FS004 FS005 FS006 FS007 FS008 WS001 WS002 WS003 WS004 WS005 WS006 WS007 WS008 WS009 KB006
Identity
- Device Name
- Hand Splint EUDAMED
- Model / Reference
- FS001 FS002 FS003 FS004 FS005 FS006 FS007 FS008 WS001 WS002 WS003 WS004 WS005 WS006 WS007 WS008 WS009 KB006 EUDAMEDFS008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761763 EUDAMED
- Basic UDI-DI
- 697581676HS001NA EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Hand Splint by Xiamen Huakang Orthopedic 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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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 | 697581676HS001NA | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 1f7d168c-95cc-4721-a237-28d59eaf172b 61 fields · synced Jun 18, 2026