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Wrist Brace
EUDAMEDClass I (EU MDR)
Ref MWRK201 (S/UNI/GY)Model Wrist Brace Series
Identity
- Trade Name
- Wrist Brace EUDAMED
- Device Name
- Wrist orthosis, hand/finger stabilizer and tubular support bandage EUDAMED
- Model / Reference
- Wrist Brace Series EUDAMEDMWRK201 (S/UNI/GY) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719894923116 EUDAMED
- Basic UDI-DI
- 471230298WRSG EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Wrist Brace by e-life International 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 | 471230298WRSG | Class I | Active |
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Manufacturer
- Manufacturer
- e-life International Co., Ltd.
- EUDAMED SRN
- TW-MF-000009901
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 475fc179-3ad0-47ae-ad47-e0cd1d650176 61 fields · synced Jun 18, 2026