← Back to catalogue
Spine Orthoses
EUDAMEDClass I (EU MDR)
Ref BA-OS-11 M/LModel Orthopedic Supports -1Ref BA-OS-11 XXLRef WA-OS-11 S/MRef WA-OS-11 L/XLRef WA-OS-12 L/XLRef WA-OS-12 XXLRef BA-OS-11 SRef WA-OS-11 XXL
Identity
- Trade Name
- SPINE ORTHOSES EUDAMED
- Device Name
- Ankle support/Wrist splint/knee support/thumb support EUDAMED
- Model / Reference
- Orthopedic Supports -1 EUDAMEDBA-OS-11 M/L EUDAMEDBA-OS-11 XXL EUDAMEDWA-OS-11 S/M EUDAMEDWA-OS-11 L/XL EUDAMEDWA-OS-12 L/XL EUDAMEDWA-OS-12 XXL EUDAMEDBA-OS-11 S EUDAMEDWA-OS-11 XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00732240910558 EUDAMED00732240910572 EUDAMED00732240910466 EUDAMED00732240910473 EUDAMED00732240910527 EUDAMED00732240910534 EUDAMED00732240910541 EUDAMED00732240910480 EUDAMED
- Basic UDI-DI
- 007322409OLDERXY EUDAMED
- EMDN Code
- Y060399 SPINE 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
Spine 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Irufa Industrial Group CO., LTD.
- EUDAMED SRN
- TW-MF-000046083
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (8)
- EUDAMED aa280bd3-0688-4ad7-97b0-29d08941e9cd 61 fields · synced Oct 6, 2026
- EUDAMED e065bbb6-6d71-42c9-9232-44737da07f5f 61 fields · synced May 16, 2026
- EUDAMED b2a4fe56-5c5e-4700-abb8-e94b2da5ad5e 61 fields · synced May 16, 2026
- EUDAMED 3e19a895-caa4-4907-82ce-7ee0668ee4a1 61 fields · synced May 17, 2026
- EUDAMED af7f9c9b-75f5-4919-a700-d59281d3584d 61 fields · synced May 18, 2026
- EUDAMED c5f67351-c307-49ee-8b65-32847a8ece7d 61 fields · synced May 18, 2026
- EUDAMED f2d8c2ff-a769-4987-9a17-e9d7e7d70fb3 61 fields · synced May 18, 2026
- EUDAMED 0024c9d2-43ae-4cf2-9032-8bb0da36d00e 61 fields · synced May 18, 2026