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ROM Knee Support/Hinged Knee Support
EUDAMEDClass I (EU MDR)
Ref KN-OS-23-ROM-1 XSModel Knee Support/Ankle Support/Lower extremity orthosesRef KN-OS-23-ROM-2 3XL Ref KN-OS-23-ROM-1 SRef KN-OS-23-ROM-2 LRef KN-OS-23-ROM-2 XLRef KN-OS-23-ROM-2 S
Identity
- Trade Name
- ROM Knee Support/Hinged Knee Support EUDAMED
- Device Name
- Knee Support/Ankle Support/Knee Sleeve/Ankle support EUDAMED
- Model / Reference
- Knee Support/Ankle Support/Lower extremity orthoses EUDAMEDKN-OS-23-ROM-1 XS EUDAMEDKN-OS-23-ROM-2 3XL EUDAMEDKN-OS-23-ROM-1 S EUDAMEDKN-OS-23-ROM-2 L EUDAMEDKN-OS-23-ROM-2 XL EUDAMEDKN-OS-23-ROM-2 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961661903 EUDAMED04719961662030 EUDAMED04719961661910 EUDAMED04719961662009 EUDAMED04719961662016 EUDAMED04719961661989 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
ROM Knee Support/Hinged Knee 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 (6)
- EUDAMED ad6cb396-2d2b-46ec-91d3-68a71c0e075d 61 fields · synced Oct 6, 2026
- EUDAMED e8338a96-ec90-4931-b3fb-71e4ab67f26f 61 fields · synced May 16, 2026
- EUDAMED b7068ed2-19bf-4c68-80e0-a405b346e545 61 fields · synced May 17, 2026
- EUDAMED 56759f16-bc46-4d8e-854b-6e153250cc02 61 fields · synced May 17, 2026
- EUDAMED 4ec58c5d-a9c1-4e67-bd28-760b6a4b7f3d 61 fields · synced May 19, 2026
- EUDAMED caffcec5-d7a7-483d-87cf-ec55f06c02cb 61 fields · synced May 19, 2026