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Knee Sleeve/Knee Support/Knee Brace
EUDAMEDClass I (EU MDR)
Ref KN-SF-13A MModel Knee Support/Ankle Support/Lower extremity orthosesRef KN-SF-13A SRef KN-SF-13 S
Identity
- Trade Name
- Knee Sleeve/Knee Support/Knee Brace EUDAMED
- Device Name
- Knee Support/Ankle Support/Knee Sleeve/Ankle support EUDAMED
- Model / Reference
- Knee Support/Ankle Support/Lower extremity orthoses EUDAMEDKN-SF-13A M EUDAMEDKN-SF-13A S EUDAMEDKN-SF-13 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961661743 EUDAMED04719961661736 EUDAMED04719961661729 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
Knee Sleeve/Knee Support/Knee Brace 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 (3)
- EUDAMED bc4efcf0-5a55-4dae-a6cd-7429cc7c3151 61 fields · synced Jul 10, 2026
- EUDAMED f47f7c12-02bd-4e42-8936-d4616f9c4e63 61 fields · synced May 18, 2026
- EUDAMED 68481937-2121-4c70-a934-cc23843044db 61 fields · synced May 18, 2026