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Hinged Knee Stabilizer / Knee Brace
EUDAMEDClass I (EU MDR)
Ref KN-SF-15-H1 XLModel Knee Support/Ankle Support/Lower extremity orthosesRef KN-SF-15-H1 XSRef KN-SF-15-H1 3XLRef KN-SF-15-H1 XXL
Identity
- Trade Name
- Hinged Knee Stabilizer / 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-15-H1 XL EUDAMEDKN-SF-15-H1 XS EUDAMEDKN-SF-15-H1 3XL EUDAMEDKN-SF-15-H1 XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961662238 EUDAMED04719961662191 EUDAMED04719961662252 EUDAMED04719961662245 EUDAMED
- Basic UDI-DI
- 471996166LOWERRA EUDAMED
- EMDN Code
- Y061209 KNEE 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
Hinged Knee Stabilizer / 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 (4)
- EUDAMED 5bee9116-1d0a-4448-9c4b-851c3fc4cb7a 61 fields · synced Oct 6, 2026
- EUDAMED 6675437a-a899-463f-9b8c-20afc0ac1760 61 fields · synced May 18, 2026
- EUDAMED fe5eca85-86b1-406d-a8b4-28d8076bd31b 61 fields · synced May 18, 2026
- EUDAMED e3263de8-f53b-481f-be83-0f0e8875d98f 61 fields · synced May 19, 2026