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WellFit Wrist Lacer Spica
EUDAMEDClass I (EU MDR)
Ref 412106(M/Right/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 410011(XL/Left/Black)Ref 412106(XL/Right/Black)Ref 410011(S/Left/Black)Ref 412106(M/Left/Black)Ref 412106(L/Left/Black)Ref 410011(M/Right/Black)Ref 412106(S/Right/Black)Ref 412106(S/Left/Black)Ref 410011(L/Left/Black)
Identity
- Trade Name
- WellFit Wrist Lacer Spica EUDAMEDWellFit Wrist Lacer 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 EUDAMED412106(M/Right/Black) EUDAMED410011(XL/Left/Black) EUDAMED412106(XL/Right/Black) EUDAMED410011(S/Left/Black) EUDAMED412106(M/Left/Black) EUDAMED412106(L/Left/Black) EUDAMED410011(M/Right/Black) EUDAMED412106(S/Right/Black) EUDAMED412106(S/Left/Black) EUDAMED410011(L/Left/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964464174 EUDAMED04719964463993 EUDAMED04719964464211 EUDAMED04719964463931 EUDAMED04719964464167 EUDAMED04719964464181 EUDAMED04719964463962 EUDAMED04719964464150 EUDAMED04719964464143 EUDAMED04719964463979 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 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 Lacer 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 (10)
- EUDAMED 4172d782-3f1d-41ca-8c28-467e2d405e98 61 fields · synced Oct 6, 2026
- EUDAMED 0cda4b82-d668-43d0-aae6-b73e80602039 61 fields · synced May 11, 2026
- EUDAMED 8bbd132c-c79a-4d1f-bf5f-456a80acd565 61 fields · synced May 16, 2026
- EUDAMED db394615-f23b-490f-9afd-30a852c4cd7a 61 fields · synced May 16, 2026
- EUDAMED 56da1a34-94ad-47f7-bf5a-889511e73c34 61 fields · synced May 16, 2026
- EUDAMED 2f066f0f-b492-4a6d-aa37-df0d5edcd419 61 fields · synced May 17, 2026
- EUDAMED e99e221d-f3f6-442d-8a8e-65ae53a39b9c 61 fields · synced May 17, 2026
- EUDAMED 5bedc620-4540-47f3-a039-4264a9303df9 61 fields · synced May 18, 2026
- EUDAMED 6d631bb8-9a40-4e42-b91d-6b0ca6cfe849 61 fields · synced May 19, 2026
- EUDAMED a1709d43-3bf2-4607-abea-8af757f622fd 61 fields · synced May 19, 2026