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Wrist Splint With Thumb
EUDAMEDClass I (EU MDR)
Ref 412103(M/Right/Gray&Silver)Model Universal Wrist Brace:410001 Wrap-around Wrist Brace:410002 Wrist/ Forearm Splint:410003 Wrist Brace:410004 Wrist Brace:410005 Wrist Splint:410006 Wrist Brace:410007 Universal Wrist Splint:410008 etcRef 412103(XL/Right/Gray&Silver)Ref 412103(L/Left/Gray&Silver)Ref 412103(XL/Left/Gray&Silver)Ref 412103(S/Left/Gray&Silver)
Identity
- Trade Name
- Wrist Splint With Thumb EUDAMED
- Device Name
- Wrist Splint (Wrist orthosis) EUDAMED
- Model / Reference
- Universal Wrist Brace:410001 Wrap-around Wrist Brace:410002 Wrist/ Forearm Splint:410003 Wrist Brace:410004 Wrist Brace:410005 Wrist Splint:410006 Wrist Brace:410007 Universal Wrist Splint:410008 etc EUDAMED412103(M/Right/Gray&Silver) EUDAMED412103(XL/Right/Gray&Silver) EUDAMED412103(L/Left/Gray&Silver) EUDAMED412103(XL/Left/Gray&Silver) EUDAMED412103(S/Left/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892937894 EUDAMED04719892937931 EUDAMED04719892937863 EUDAMED04719892937924 EUDAMED04719892937900 EUDAMED
- Basic UDI-DI
- 47199644641WC EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Wrist Splint With Thumb by Orthotech Rehabilitation 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 | 47199644641WC | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 19d9f243-f5a7-45ed-a9b5-fcc5aea845e0 61 fields · synced Oct 6, 2026
- EUDAMED 3180615c-2299-42c5-a794-1cd7438da3d1 61 fields · synced May 16, 2026
- EUDAMED 878cc1d2-7fd6-447b-8967-95d9d72f3cd3 61 fields · synced May 17, 2026
- EUDAMED 3dadc7e1-ce9b-4a1a-ac41-1ca946b99cd3 61 fields · synced May 17, 2026
- EUDAMED 8db41f08-7b6d-4ac3-bd15-fc164a5d4ef5 61 fields · synced May 18, 2026