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Shoulder Support/ Shoulder Brace/Shoulder Wrap
EUDAMEDClass I (EU MDR)
Ref Shoulder-OS-11 RegularModel Shoulder Support/ Shoulder Brace/ shoulder orthosesRef Shoulder-OS-11 S
Identity
- Trade Name
- Shoulder Support/ Shoulder Brace/Shoulder Wrap EUDAMED
- Device Name
- Shoulder Support/ Shoulder Brace/Shoulder Wrap EUDAMED
- Model / Reference
- Shoulder Support/ Shoulder Brace/ shoulder orthoses EUDAMEDShoulder-OS-11 Regular EUDAMEDShoulder-OS-11 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961660838 EUDAMED04719961660852 EUDAMED
- Basic UDI-DI
- 471996166SHOULDERR5 EUDAMED
- EMDN Code
- Y060621 SHOULDER ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Shoulder Support/ Shoulder Brace/Shoulder 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 | 471996166SHOULDERR5 | 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 (2)
- EUDAMED a9af5801-97c5-4781-a558-588dbcdf758e 61 fields · synced Oct 6, 2026
- EUDAMED d0dc9ca1-257c-44a9-92ee-da121b7f3402 61 fields · synced May 19, 2026