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Wrist/ Forearm Splint
EUDAMEDClass I (EU MDR)
Ref 410003(XS/Left/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 410003(M/Right/Gray&Silver)Ref 410003(L/Right/Gray&Silver)Ref 410003(S/Right/Gray&Silver)
Identity
- Trade Name
- Wrist/ Forearm Splint 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 EUDAMED410003(XS/Left/Gray&Silver) EUDAMED410003(M/Right/Gray&Silver) EUDAMED410003(L/Right/Gray&Silver) EUDAMED410003(S/Right/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964467496 EUDAMED04719892937498 EUDAMED04719892937474 EUDAMED04719892937511 EUDAMED
- Basic UDI-DI
- 47199644641WC EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) 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/ Forearm Splint 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 (4)
- EUDAMED 1489bf12-f15c-4d6e-bf36-3ab6a2746721 61 fields · synced Oct 6, 2026
- EUDAMED cb157c1d-e869-47d0-be75-e10710647a58 61 fields · synced May 17, 2026
- EUDAMED c2c6781f-6ec3-4ea0-8371-542bf9c48642 61 fields · synced May 17, 2026
- EUDAMED fa1adf9f-d472-4f15-9af7-2121bcb782f1 61 fields · synced May 19, 2026