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Hand Splint
EUDAMEDClass I (EU MDR)
Ref FS001 FS002 FS003 FS004 FS005 FS006 FS007 FS008 WS001 WS002 WS003 WS004 WS005 WS006 WS007 WS008 WS009 KB006Ref WS002Ref WS008Ref FS003Ref FS006Ref FS002Ref WS001Ref WS005Ref FS004
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 EUDAMEDWS002 EUDAMEDWS008 EUDAMEDFS003 EUDAMEDFS006 EUDAMEDFS002 EUDAMEDWS001 EUDAMEDWS005 EUDAMEDFS004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816760056 EUDAMED06975816761800 EUDAMED06975816761862 EUDAMED06975816761718 EUDAMED06975816761749 EUDAMED06975816761701 EUDAMED06975816761794 EUDAMED06975816761831 EUDAMED06975816761725 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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- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
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- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- 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 | 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 (9)
- EUDAMED b48504cd-817d-418c-b7e1-03008ad8da21 61 fields · synced Sep 18, 2026
- EUDAMED a2a4e7f5-eefc-4b35-ad15-f3f5e514b008 61 fields · synced May 18, 2026
- EUDAMED 8ca4d695-5805-4a1e-8573-dd299e6eeb8b 61 fields · synced May 18, 2026
- EUDAMED b8e6bdd8-093d-4b29-9e26-67e610e7cae4 61 fields · synced May 18, 2026
- EUDAMED 66f0c9fa-ac2e-4b25-989c-720c2f90032f 61 fields · synced May 18, 2026
- EUDAMED 8c8710e2-0a02-4c76-9b83-fef2d6355560 61 fields · synced May 18, 2026
- EUDAMED 9d2824d6-f331-4f01-9d26-2dc1559adcb0 61 fields · synced May 18, 2026
- EUDAMED e64d1e23-57fe-4242-be90-abc993418035 61 fields · synced May 18, 2026
- EUDAMED f5ba0c7e-0255-46ee-a5a9-96f3b98038a7 61 fields · synced May 19, 2026