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Patella Knee Strap/Patella Straps
EUDAMEDClass I (EU MDR)
Ref KN-OS-62 SModel Knee Support/Ankle Support/Lower extremity orthosesRef KN-OS-61Model Orthopedic Supports -1Ref KN-OS-62 XL
Identity
- Trade Name
- Patella Knee Strap/Patella Straps EUDAMEDPatella Knee Strap EUDAMED
- Device Name
- Knee Support/Ankle Support/Knee Sleeve/Ankle support EUDAMEDAnkle support/Wrist splint/knee support/thumb support EUDAMED
- Model / Reference
- Knee Support/Ankle Support/Lower extremity orthoses EUDAMEDKN-OS-62 S EUDAMEDKN-OS-61 EUDAMEDOrthopedic Supports -1 EUDAMEDKN-OS-62 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961662160 EUDAMED04719961662153 EUDAMED00732240910763 EUDAMED00732240910787 EUDAMED
- Basic UDI-DI
- 471996166LOWERRA EUDAMED007322409OLDERXY EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMEDY061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMEDNorthern Ireland 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
Patella Knee Strap/Patella Straps 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 34df7e62-b6d4-4e5f-b659-07c71de93890 61 fields · synced Jul 19, 2026
- EUDAMED 06c6af25-a24a-41a5-9bf2-7cdb0a5ed0cd 61 fields · synced May 18, 2026
- EUDAMED 0eb6483d-e424-4d21-8deb-05def1c2a7ac 61 fields · synced May 18, 2026
- EUDAMED b199e70d-4b48-4055-ac07-c78dfb9ff61f 61 fields · synced May 18, 2026