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Lower Extremity Orthoses
EUDAMEDClass I (EU MDR)
Ref AN-SF-01 XSModel Orthopedic Supports -1
Identity
- Trade Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Device Name
- Ankle support/Wrist splint/knee support/thumb support EUDAMED
- Model / Reference
- Orthopedic Supports -1 EUDAMEDAN-SF-01 XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00732240910596 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
Lower Extremity Orthoses 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 (1)
- EUDAMED 8535ed02-6940-4a03-9e5e-703ebecf08a4 61 fields · synced Jun 18, 2026