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Q-Fit Low Profile Back Brace
EUDAMEDClass I (EU MDR)
Ref MWAQF04 (M/UNI/BK)Model Waist Support Series
Identity
- Trade Name
- Q-Fit Low Profile Back Brace EUDAMED
- Device Name
- Multiple spinal region orthosis and abdominal binder EUDAMED
- Model / Reference
- Waist Support Series EUDAMEDMWAQF04 (M/UNI/BK) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712302987625 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
Q-Fit Low Profile Back 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 172c3326-1c41-4f08-ae9a-f89a75c7c04c 61 fields · synced Jun 18, 2026