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Spacer Fabric Knee Support Wrap
EUDAMEDClass I (EU MDR)
Ref KN-OS-18 OModel Orthopedic Supports -1Ref KN-OS-33 LRef KN-OS-33 MRef KN-OS-17 ORef KN-OS-33 S
Identity
- Trade Name
- Spacer Fabric Knee Support Wrap EUDAMED
- Device Name
- Ankle support/Wrist splint/knee support/thumb support EUDAMED
- Model / Reference
- Orthopedic Supports -1 EUDAMEDKN-OS-18 O EUDAMEDKN-OS-33 L EUDAMEDKN-OS-33 M EUDAMEDKN-OS-17 O EUDAMEDKN-OS-33 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00732240910275 EUDAMED00727522086779 EUDAMED00727522086762 EUDAMED00732240910251 EUDAMED00727522086755 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 Support Wrap 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 (5)
- EUDAMED af4c1a00-1f39-4f1a-848d-7180a49d2e7e 61 fields · synced Sep 17, 2026
- EUDAMED 31cd95f3-182e-474a-bfce-b1fdee2f1356 61 fields · synced May 17, 2026
- EUDAMED 35c0444c-37bf-46f4-873b-8d8c904f684e 61 fields · synced May 18, 2026
- EUDAMED f34ca5a4-a734-476e-b916-deaf971b1a05 61 fields · synced May 18, 2026
- EUDAMED c0cb9196-0f33-44ad-8c04-b374b4e74c1a 61 fields · synced May 18, 2026