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Back Brace/Lumbosacral Support
EUDAMEDClass I (EU MDR)
Ref BA-SF-602 MModel Back support/Faja sacrolumbar/ Waist support/
Identity
- Trade Name
- Back Brace/Lumbosacral Support EUDAMED
- Device Name
- Back support/Faja sacrolumbar/ Waist support EUDAMED
- Model / Reference
- Back support/Faja sacrolumbar/ Waist support/ EUDAMEDBA-SF-602 M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961663662 EUDAMED
- Basic UDI-DI
- 471996166WAISTR9 EUDAMED
- Direct Marketing DI
- 04719961663662 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Back Brace/Lumbosacral 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 (1)
- EUDAMED 5a63fa0e-9939-4607-ac61-531c0f4c4e1d 61 fields · synced Aug 1, 2026