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Wrap-around Wrist Support
EUDAMEDClass I (EU MDR)
Ref 416001(Universal/UNI/Black)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 etc
Identity
- Trade Name
- Wrap-around Wrist Support 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 EUDAMED416001(Universal/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872869894 EUDAMED
- Basic UDI-DI
- 47198728641WE 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
Wrap-around Wrist Support 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 (1)
- EUDAMED 7b5869c5-7d3d-42e6-911e-b766cd303fcd 61 fields · synced Oct 6, 2026