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AFO Ankle Support
EUDAMEDClass I (EU MDR)
Ref AFO-SF-11 LEFT SModel Knee Support/Ankle Support/Lower extremity orthosesRef AFO-SF-11 RIGHT MRef AFO-SF-11 RIGHT SRef AFO-SF-11 LEFT MRef AFO-SF-11 RIGHT L
Identity
- Trade Name
- AFO Ankle Support EUDAMED
- Device Name
- Knee Support/Ankle Support/Knee Sleeve/Ankle support EUDAMED
- Model / Reference
- Knee Support/Ankle Support/Lower extremity orthoses EUDAMEDAFO-SF-11 LEFT S EUDAMEDAFO-SF-11 RIGHT M EUDAMEDAFO-SF-11 RIGHT S EUDAMEDAFO-SF-11 LEFT M EUDAMEDAFO-SF-11 RIGHT L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961660692 EUDAMED04719961660746 EUDAMED04719961660739 EUDAMED04719961660708 EUDAMED04719961660753 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 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 (5)
- EUDAMED 73ae88e2-1fd4-4891-9f3f-e58c97bb397f 61 fields · synced Aug 4, 2026
- EUDAMED 71563fa7-eb72-4a63-a5cc-990b0a3b0ef8 61 fields · synced May 18, 2026
- EUDAMED eecf7e8d-2e08-4e33-939c-84f8a90b32f3 61 fields · synced May 18, 2026
- EUDAMED b3af7b63-3638-42e6-8ea5-5f1978dd4b37 61 fields · synced May 18, 2026
- EUDAMED acd3f8ea-e10b-4cf5-a097-d7785805b7cd 61 fields · synced May 19, 2026