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Spacer Fabric Ankle Wrap Support
EUDAMEDClass I (EU MDR)
Ref AN-OS-12 XLModel Knee Support/Ankle Support/Lower extremity orthosesRef AN-OS-11A LRef AN-OS-11A XLRef AN-OS-12 S
Identity
- Trade Name
- Spacer Fabric Ankle Wrap Support EUDAMEDSpacer Fabric Ankle Wrap EUDAMED
- Device Name
- Knee Support/Ankle Support/Knee Sleeve/Ankle support EUDAMED
- Model / Reference
- Knee Support/Ankle Support/Lower extremity orthoses EUDAMEDAN-OS-12 XL EUDAMEDAN-OS-11A L EUDAMEDAN-OS-11A XL EUDAMEDAN-OS-12 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961660463 EUDAMED04719961660432 EUDAMED04719961660449 EUDAMED04719961660470 EUDAMED
- Basic UDI-DI
- 471996166LOWERRA EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER 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
Spacer Fabric Ankle Wrap 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 | 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 (4)
- EUDAMED fe23e15b-f5dc-4b05-9104-5905d23f0af7 61 fields · synced Jul 30, 2026
- EUDAMED 51c96317-55d0-48f1-a83a-ccaca8f4f2e0 61 fields · synced May 17, 2026
- EUDAMED f07eebdf-7275-44f5-909c-a0609a60f0c4 61 fields · synced May 17, 2026
- EUDAMED bb5d98dc-e646-4414-9f8e-4cd4f0472e24 61 fields · synced May 18, 2026