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Back Support/Faja sacrolumbar Support/Back belt
EUDAMEDClass I (EU MDR)
Ref BA-OS-11 XLModel Back support/Faja sacrolumbar/ Waist support/Ref BA-SF-801 XXLRef BA-SF-1201 LRef BA-OS-11 XXLRef BA-OS-11 M/LRef BA-SF-1201 SRef BA-SF-801 MRef BA-OS-11 S
Identity
- Trade Name
- Back Support/Faja sacrolumbar Support/Back belt EUDAMED
- Device Name
- Back support/Faja sacrolumbar/ Waist support EUDAMED
- Model / Reference
- Back support/Faja sacrolumbar/ Waist support/ EUDAMEDBA-OS-11 XL EUDAMEDBA-SF-801 XXL EUDAMEDBA-SF-1201 L EUDAMEDBA-OS-11 XXL EUDAMEDBA-OS-11 M/L EUDAMEDBA-SF-1201 S EUDAMEDBA-SF-801 M EUDAMEDBA-OS-11 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961661026 EUDAMED04719961661088 EUDAMED04719961661118 EUDAMED04719961661033 EUDAMED04719961661019 EUDAMED04719961661095 EUDAMED04719961661057 EUDAMED04719961661002 EUDAMED
- Basic UDI-DI
- 471996166WAISTR9 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMEDY060308,Y061299 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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 Support/Faja sacrolumbar Support/Back belt 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 (8)
- EUDAMED 57a9ac2c-f4ad-4d8d-b102-bcc2ae081f9f 61 fields · synced Oct 6, 2026
- EUDAMED fd5b82d4-9edc-49b2-8014-7bfd58ff3828 61 fields · synced May 17, 2026
- EUDAMED f0dcc0c9-63e4-4c0d-a166-027512759d99 61 fields · synced May 17, 2026
- EUDAMED 36c38320-04d3-4b4c-8f54-9c03237d289d 61 fields · synced May 17, 2026
- EUDAMED f7e025e7-071e-41f7-bfcc-4d32bf41a5d8 61 fields · synced May 18, 2026
- EUDAMED eea7700f-4cca-4e27-8854-e45dec0bfc2d 61 fields · synced May 18, 2026
- EUDAMED 4118353b-3dfb-49bb-9497-339ee48b47e8 61 fields · synced May 18, 2026
- EUDAMED 48008889-5279-4477-8b8c-f9ed32643481 61 fields · synced May 18, 2026