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3D Breathable Knee Wrap/Knee Suuport
EUDAMEDClass I (EU MDR)
Ref KN-OS-16Model Knee Support/Ankle Support/Lower extremity orthosesRef KN-OS-17Ref KN-OS-18Ref KN-OS-19
Identity
- Trade Name
- 3D Breathable Knee Wrap/Knee Suuport EUDAMED
- Device Name
- Knee Support/Ankle Support/Knee Sleeve/Ankle support EUDAMED
- Model / Reference
- Knee Support/Ankle Support/Lower extremity orthoses EUDAMEDKN-OS-16 EUDAMEDKN-OS-17 EUDAMEDKN-OS-18 EUDAMEDKN-OS-19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961661866 EUDAMED04719961661873 EUDAMED04719961661880 EUDAMED04719961661897 EUDAMED
- Basic UDI-DI
- 471996166LOWERRA EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
3D Breathable Knee Wrap/Knee Suuport 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 e52f00ce-5bc5-4a10-a84b-ea46e8ee8c19 61 fields · synced Oct 6, 2026
- EUDAMED 86772896-1ef1-4de4-b9bd-dfa27e64fbf4 61 fields · synced May 18, 2026
- EUDAMED 57038539-e174-468a-aea7-71a6f3708f33 61 fields · synced May 18, 2026
- EUDAMED 3b1c4ecf-dd27-4e99-a797-01b890bbeeee 61 fields · synced May 19, 2026