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Abdominal Binder/faja Support 12 inch high
EUDAMEDClass I (EU MDR)
Ref AB-SF-1201 SModel Back support/Faja sacrolumbar/ Waist support/Ref AB-SF-901 LRef AB-SF-601 LRef AB-SF-901 MRef AB-SF-1201 XXLRef AB-SF-601 S
Identity
- Trade Name
- Abdominal Binder/faja Support 12 inch high EUDAMEDAbdominal Binder/faja Support EUDAMEDAbdominal Binder/faja Support 12 Inch High EUDAMED
- Device Name
- Back support/Faja sacrolumbar/ Waist support EUDAMED
- Model / Reference
- Back support/Faja sacrolumbar/ Waist support/ EUDAMEDAB-SF-1201 S EUDAMEDAB-SF-901 L EUDAMEDAB-SF-601 L EUDAMEDAB-SF-901 M EUDAMEDAB-SF-1201 XXL EUDAMEDAB-SF-601 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961661248 EUDAMED04719961661217 EUDAMED04719961661163 EUDAMED04719961661200 EUDAMED04719961661286 EUDAMED04719961661149 EUDAMED
- Basic UDI-DI
- 471996166WAISTR9 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDIreland 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
Abdominal Binder/faja Support 12 inch high 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 (6)
- EUDAMED 10d60ce0-3fd1-4d4a-8c72-351c6d30c089 61 fields · synced Jul 27, 2026
- EUDAMED 79660106-ee81-4735-bfa6-334e2afe1aa7 61 fields · synced May 16, 2026
- EUDAMED 50f69abc-cf77-4143-9322-c56a0caf5647 61 fields · synced May 16, 2026
- EUDAMED 1aa51398-1bc9-4df5-af3a-389fb5b892d6 61 fields · synced May 17, 2026
- EUDAMED 83387bed-5e6e-486d-9439-ac64c7d07c43 61 fields · synced May 17, 2026
- EUDAMED efeafbaf-764c-4e4b-86d8-a4625888fd10 61 fields · synced May 17, 2026