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Hand Splint
EUDAMEDClass I (EU MDR)
Ref FS007Model 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 EUDAMEDFS007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761756 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
Hand Splint by Xiamen Huakang Orthopedic 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 | 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 d469c41f-6380-408e-add1-8a58351e5619 61 fields · synced Jun 18, 2026