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Spacer Fabric Knee sleeve
EUDAMEDClass I (EU MDR)
Ref KN-SF-13 XLModel Orthopedic Supports -1Ref KN-SF-13 XXLRef KN-SF-13 S
Identity
- Trade Name
- Spacer Fabric Knee sleeve EUDAMED
- Device Name
- Ankle support/Wrist splint/knee support/thumb support EUDAMED
- Model / Reference
- Orthopedic Supports -1 EUDAMEDKN-SF-13 XL EUDAMEDKN-SF-13 XXL EUDAMEDKN-SF-13 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00732240910848 EUDAMED00732240910855 EUDAMED00732240910817 EUDAMED
- Basic UDI-DI
- 007322409OLDERXY EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER 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
Spacer Fabric Knee sleeve 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 | 007322409OLDERXY | 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 c3b66c9f-3410-4b48-a6d9-f1cecbd9774d 61 fields · synced Oct 6, 2026
- EUDAMED 035c341e-5ac0-463d-a4df-81450bd7a185 61 fields · synced May 17, 2026
- EUDAMED 78f82b90-2190-4d1f-ad4b-f1a3a201be2c 61 fields · synced May 19, 2026