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Scoliosis Orthosis
EUDAMEDClass I (EU MDR)
Ref MWA0008 (Universal/UNI/BK)Model Waist Support Series
Identity
- Trade Name
- Scoliosis Orthosis EUDAMED
- Device Name
- Multiple spinal region orthosis and abdominal binder EUDAMED
- Model / Reference
- Waist Support Series EUDAMEDMWA0008 (Universal/UNI/BK) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719894927596 EUDAMED
- Basic UDI-DI
- 471230298WARE EUDAMED
- EMDN Code
- Y060309 THORACOLUMBOSACRAL SPINE 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
Scoliosis 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 | 471230298WARE | 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 617a8ffd-6f5c-46ec-b042-633c7112e6d1 61 fields · synced Jul 16, 2026