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Thermo Lumbar Brace
EUDAMEDClass I (EU MDR)
Ref SWATM01 (S/UNI/BK)Model Waist Support Series
Identity
- Trade Name
- Thermo Lumbar Brace EUDAMED
- Device Name
- Multiple spinal region orthosis and abdominal binder EUDAMED
- Model / Reference
- Waist Support Series EUDAMEDSWATM01 (S/UNI/BK) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710374236184 EUDAMED
- Basic UDI-DI
- 471230298WARE EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL 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
Thermo Lumbar 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 | 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 bff30c4c-3fe9-43dd-9b70-0c05a39641c6 61 fields · synced Jun 19, 2026