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Waist support/Back support/Lumbar support
EUDAMEDClass I (EU MDR)
Ref WA-OS-11 XXLModel Back support/Faja sacrolumbar/ Waist support/Ref WA-OS-12 S/MRef WA-OS-11 L/XLRef WA-OS-12 L/XL
Identity
- Trade Name
- Waist support/Back support/Lumbar support EUDAMED
- Device Name
- Back support/Faja sacrolumbar/ Waist support EUDAMED
- Model / Reference
- Back support/Faja sacrolumbar/ Waist support/ EUDAMEDWA-OS-11 XXL EUDAMEDWA-OS-12 S/M EUDAMEDWA-OS-11 L/XL EUDAMEDWA-OS-12 L/XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961660968 EUDAMED04719961660975 EUDAMED04719961660951 EUDAMED04719961660982 EUDAMED
- Basic UDI-DI
- 471996166WAISTR9 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDCzechia EUDAMEDFinland 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
Waist support/Back support/Lumbar support by Irufa Industrial Group 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 | 471996166WAISTR9 | Class I | Active |
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Manufacturer
- Manufacturer
- Irufa Industrial Group CO., LTD.
- EUDAMED SRN
- TW-MF-000046083
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (4)
- EUDAMED 87064ca4-9702-4aab-a26e-eb344e8f352b 61 fields · synced Aug 3, 2026
- EUDAMED c43ecafe-c5a6-485c-adc8-91007e4fcb20 61 fields · synced May 17, 2026
- EUDAMED b6aee260-6dd4-4711-9382-a60ce79be5db 61 fields · synced May 18, 2026
- EUDAMED 24768820-c987-48f0-8398-d586baaafebe 61 fields · synced May 19, 2026