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Palm Brace
EUDAMEDClass I (EU MDR)
Ref 412001(L/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 412001(M/UNI/Gray&Silver)
Identity
- Trade Name
- Palm 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 EUDAMED412001(L/UNI/Gray&Silver) EUDAMED412001(M/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872862482 EUDAMED04719872862499 EUDAMED
- Basic UDI-DI
- 47198728641WE 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
Palm Brace 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 (2)
- EUDAMED bed5fcf6-1be7-4650-8b67-dfe2c1feed15 61 fields · synced Oct 7, 2026
- EUDAMED 3788fd73-4f12-4dd3-a280-d5d93289ceb5 61 fields · synced May 19, 2026