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Spacer Fabric Wrist Splint Sleeve
EUDAMEDClass I (EU MDR)
Ref WS-SF-12 LEFT LModel Wrist Splint/ Wrist sleeve/ Wrist support
Identity
- Trade Name
- Spacer Fabric Wrist Splint Sleeve EUDAMED
- Device Name
- Wrist Splint/ Wrist sleeve/ Wrist support/Wrist Brace EUDAMED
- Model / Reference
- Wrist Splint/ Wrist sleeve/ Wrist support EUDAMEDWS-SF-12 LEFT L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961660036 EUDAMED
- Basic UDI-DI
- 471996166UPPERTH EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - 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 Wrist Splint Sleeve 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 | 471996166UPPERTH | 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 aa8cb9d3-f90b-4730-a7b9-2ef66d83c3ae 61 fields · synced Jun 18, 2026