← Back to catalogue
Waist support/Back support/Lumbar support
EUDAMEDClass I (EU MDR)
Ref WA-OS-12 XXLModel Back support/Faja sacrolumbar/ Waist support/
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-12 XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961660999 EUDAMED
- Basic UDI-DI
- 471996166WAISTR9 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Irufa Industrial Group CO., LTD.
- EUDAMED SRN
- TW-MF-000046083
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 686e13cc-6406-46be-aa25-d67ec8056756 61 fields · synced Jun 18, 2026