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CTS Wrist Orthosis
EUDAMEDClass I (EU MDR)
Ref 410009(XS/UNI/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 410009(M/UNI/Black)Ref 410009(XS/UNI/Black)Ref 410009(L/UNI/Gray&Silver)Ref 410009(S/UNI/Gray&Silver)Ref 410009(XL/UNI/Gray&Silver)
Identity
- Trade Name
- CTS Wrist Orthosis 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 EUDAMED410009(XS/UNI/Gray&Silver) EUDAMED410009(M/UNI/Black) EUDAMED410009(XS/UNI/Black) EUDAMED410009(L/UNI/Gray&Silver) EUDAMED410009(S/UNI/Gray&Silver) EUDAMED410009(XL/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892938013 EUDAMED04719964469230 EUDAMED04719964469216 EUDAMED04719892937986 EUDAMED04719892938006 EUDAMED04719964465799 EUDAMED
- Basic UDI-DI
- 47199644641WC EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
CTS Wrist Orthosis 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 (6)
- EUDAMED cebf8b11-aafc-4c96-88c7-2a4e667e963e 61 fields · synced Oct 6, 2026
- EUDAMED a7687a13-a2a2-488b-8973-0bc5a4a21094 61 fields · synced May 17, 2026
- EUDAMED 69ff6e41-ccf4-4755-b605-fa81e0347a67 61 fields · synced May 17, 2026
- EUDAMED 6ebab4a9-16bd-433b-b570-38a052da4de0 61 fields · synced May 17, 2026
- EUDAMED 56b8ffdf-f2ac-4147-b81e-83f07f04610d 61 fields · synced May 17, 2026
- EUDAMED 791183fa-9eeb-40c2-9b42-f5424558e33e 61 fields · synced May 19, 2026