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Hinged Wrist Hand Orthosis
EUDAMEDClass I (EU MDR)
Ref MWRFN70 (XL/Right/WH)Model Wrist Brace Series
Identity
- Trade Name
- Hinged Wrist Hand Orthosis EUDAMED
- Device Name
- Wrist orthosis, hand/finger stabilizer and tubular support bandage EUDAMED
- Model / Reference
- Wrist Brace Series EUDAMEDMWRFN70 (XL/Right/WH) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712302984341 EUDAMED
- Basic UDI-DI
- 471230298WRSG EUDAMED
- EMDN Code
- Y060612 WRIST-HAND 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
Hinged Wrist Hand Orthosis 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 30e2422e-8d1e-4807-b646-ee1649dca893 61 fields · synced Jun 19, 2026