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WellFit Wrist Brace Spica
EUDAMEDClass I (EU MDR)
Ref 412105(S/Left/Black)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 412105(M/Left/Black)Ref 410010(L/Left/Black)Ref 412105(M/Right/Black)Ref 410010(S/Right/Black)Ref 412105(S/Right/Black)Ref 410010(L/Right/Black)Ref 412105(L/Right/Black)Ref 412105(L/Left/Black)
Identity
- Trade Name
- WellFit Wrist Brace Spica EUDAMEDWellFit Wrist Brace 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 EUDAMED412105(S/Left/Black) EUDAMED412105(M/Left/Black) EUDAMED410010(L/Left/Black) EUDAMED412105(M/Right/Black) EUDAMED410010(S/Right/Black) EUDAMED412105(S/Right/Black) EUDAMED410010(L/Right/Black) EUDAMED412105(L/Right/Black) EUDAMED412105(L/Left/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964464068 EUDAMED04719964464082 EUDAMED04719964463894 EUDAMED04719964464099 EUDAMED04719964463863 EUDAMED04719964464075 EUDAMED04719964463900 EUDAMED04719964464112 EUDAMED04719964464105 EUDAMED
- Basic UDI-DI
- 47199644641WC EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMEDY060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDIreland 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
WellFit Wrist Brace Spica 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 (9)
- EUDAMED 82bb849b-7de2-4d1a-8b7e-6aac27c6300b 61 fields · synced Oct 6, 2026
- EUDAMED a41e66a8-29c0-4288-93bc-b32e286a290f 61 fields · synced May 11, 2026
- EUDAMED 3da14c36-bd47-4699-9041-53ce19aeb78e 61 fields · synced May 18, 2026
- EUDAMED 82b4b777-dfd2-4fe7-8e8c-18d31a3c391b 61 fields · synced May 19, 2026
- EUDAMED 41dd49d8-456c-457c-9e2d-c898fb67a893 61 fields · synced May 19, 2026
- EUDAMED c577e079-5b20-4472-9d99-476531e940cf 61 fields · synced May 19, 2026
- EUDAMED 1b55bd32-390e-43e4-b406-71cbae65e8ca 61 fields · synced May 19, 2026
- EUDAMED fda6b7ac-0247-47ac-88ef-2b09f1eaad49 61 fields · synced May 19, 2026
- EUDAMED 4e7e9661-9e88-4dc4-a45f-a426de250b40 61 fields · synced May 19, 2026