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CTS Wrist Orthosis
EUDAMEDClass I (EU MDR)
Ref 410009(M/UNI/Gray&Silver)Model Athena Wrist Support:412003 CTS Wrist Orthosis:410009 Functional Position Splint:417001 Palm Brace:412001 Thumb Brace:412102 Thumb Brace:418003 Thumb Splint:412101 TPS THUMB BRACE:416601 TPS WRIST AND THUMB SPLINT:416602 Uni Thumb Brace:412104 etcRef 410009(XL/UNI/Gray&Silver)Ref 410009(S/UNI/Black)Ref 410009(M/UNI/Black)Ref 410009(XS/UNI/Gray&Silver)Ref 417001(M/Right/Gray&Silver)Ref 410009(L/UNI/Black)Ref 410009(S/UNI/Gray&Silver)Ref 412102(L/Right/Black)Ref 410009(XL/UNI/Black)Ref 410009(XS/UNI/Black)
Identity
- Trade Name
- CTS Wrist Orthosis EUDAMEDFunctional Position Splint EUDAMEDThumb Brace EUDAMED
- Device Name
- Wrist Splint (Wrist orthosis) EUDAMED
- Model / Reference
- Athena Wrist Support:412003 CTS Wrist Orthosis:410009 Functional Position Splint:417001 Palm Brace:412001 Thumb Brace:412102 Thumb Brace:418003 Thumb Splint:412101 TPS THUMB BRACE:416601 TPS WRIST AND THUMB SPLINT:416602 Uni Thumb Brace:412104 etc EUDAMED410009(M/UNI/Gray&Silver) EUDAMED410009(XL/UNI/Gray&Silver) EUDAMED410009(S/UNI/Black) EUDAMED410009(M/UNI/Black) EUDAMED410009(XS/UNI/Gray&Silver) EUDAMED417001(M/Right/Gray&Silver) EUDAMED410009(L/UNI/Black) EUDAMED410009(S/UNI/Gray&Silver) EUDAMED412102(L/Right/Black) EUDAMED410009(XL/UNI/Black) EUDAMED410009(XS/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872863236 EUDAMED04719892931465 EUDAMED04719964469179 EUDAMED04719964469186 EUDAMED04719872863267 EUDAMED04719872862659 EUDAMED04719964469193 EUDAMED04719872863243 EUDAMED04719892932219 EUDAMED04719964469209 EUDAMED04719964469162 EUDAMED
- Basic UDI-DI
- 47198728641WE EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMEDY060613 WRIST-HAND-FINGERS ORTHOSES EUDAMEDY060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMEDPoland 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 Zhangpu Ortholife 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 | 47198728641WE | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (11)
- EUDAMED 1376ca63-bace-4dc5-869d-593a4623b060 61 fields · synced Oct 7, 2026
- EUDAMED 6da61f75-fc75-46b9-ba0a-2a43d637b67f 61 fields · synced May 16, 2026
- EUDAMED 8376cb14-c098-4e54-abfe-8ffc393359d8 61 fields · synced May 17, 2026
- EUDAMED 0a178bdd-15f7-436a-9480-3099a07fa944 61 fields · synced May 17, 2026
- EUDAMED e82ce5dc-1622-4851-8844-94dad5e1ba31 61 fields · synced May 17, 2026
- EUDAMED 7f72920c-f046-4e70-9a1e-267e195569bf 61 fields · synced May 17, 2026
- EUDAMED 3db4e496-da31-41d6-b159-be6518fdd574 61 fields · synced May 18, 2026
- EUDAMED 0ade0f8e-a80f-4990-929b-8f3784663ea8 61 fields · synced May 19, 2026
- EUDAMED 337093ee-a720-4c9d-9066-25c2104b05e4 61 fields · synced May 19, 2026
- EUDAMED 6e1efa96-e820-4718-b7e3-87f7aab54262 61 fields · synced May 19, 2026
- EUDAMED 8fcc5144-2240-48cf-bcc7-9081b8b8dd96 61 fields · synced May 19, 2026