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Lower Extremity Orthoses
EUDAMEDClass I (EU MDR)
Ref AN-SF-01 3XLModel Orthopedic Supports -1Ref AN-SF-01 MRef AN-SF-01 LRef AN-OS-11 LRef AN-OS-12 S
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 3XL EUDAMEDAN-SF-01 M EUDAMEDAN-SF-01 L EUDAMEDAN-OS-11 L EUDAMEDAN-OS-12 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00732240911005 EUDAMED00732240910893 EUDAMED00732240910909 EUDAMED00732240910664 EUDAMED00732240911104 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 (5)
- EUDAMED e22429f6-d013-4f4b-9ee8-ced634064a2a 61 fields · synced Oct 6, 2026
- EUDAMED eb8e67fc-f307-4f93-9130-0c8ecb974d66 61 fields · synced May 17, 2026
- EUDAMED 785fea2d-8d0b-4a8f-ac13-5b40caead406 61 fields · synced May 17, 2026
- EUDAMED 39a4888c-9266-4b68-94ce-bed4b9c6cc54 61 fields · synced May 18, 2026
- EUDAMED d0cd3d18-982f-45c3-bbd2-4e08c6f24bc0 61 fields · synced May 18, 2026