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AFO Ankle Stabilizer Support
EUDAMEDClass I (EU MDR)
Ref AFO-SF-21 RIGHT L/XLModel Knee Support/Ankle Support/Lower extremity orthoses
Identity
- Trade Name
- AFO Ankle Stabilizer Support EUDAMED
- Device Name
- Knee Support/Ankle Support/Knee Sleeve/Ankle support EUDAMED
- Model / Reference
- Knee Support/Ankle Support/Lower extremity orthoses EUDAMEDAFO-SF-21 RIGHT L/XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961662313 EUDAMED
- Basic UDI-DI
- 471996166LOWERRA EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Category: Ankle/foot orthosis
AFO Ankle Stabilizer Support by Irufa Industrial Group CO., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 471996166LOWERRA | 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 340230b4-9329-4bc6-ad02-c9e3be09357b 61 fields · synced Jun 18, 2026