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WellKnit Wrist Brace
EUDAMEDClass I (EU MDR)
Ref 414001(M/UNI/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 414001(XL/UNI/Black)Ref 414001(L/UNI/Black)Ref 414001(S/UNI/Black)
Identity
- Trade Name
- WellKnit 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 EUDAMED414001(M/UNI/Black) EUDAMED414001(XL/UNI/Black) EUDAMED414001(L/UNI/Black) EUDAMED414001(S/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964466819 EUDAMED04719964466802 EUDAMED04719892938020 EUDAMED04719964466826 EUDAMED
- Basic UDI-DI
- 47199644641WC EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
WellKnit Wrist Brace 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 a2393093-d390-4b73-a7ac-0e378a83554f 61 fields · synced Oct 7, 2026
- EUDAMED bcedb0bf-db77-40fa-921f-2f7add6a9e8b 61 fields · synced May 17, 2026
- EUDAMED f29f6c5b-f0f8-4cf5-947b-ea6d214fd0f1 61 fields · synced May 19, 2026
- EUDAMED 422af54e-c58e-4353-8102-136f4ba60e09 61 fields · synced May 19, 2026