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Spacer Fabric Wrist Splint Sleeve
EUDAMEDClass I (EU MDR)
Ref WS-SF-12 LEFT MModel Wrist Splint/ Wrist sleeve/ Wrist supportRef WS-SF-12 RIGHT SRef WS-SF-12 RIGHT LRef WS-SF-23 LEFT SModel Irufa Wrist Brace/Wrist Splint/Wrist Support Ref WS-SF-12 LEFT XLRef WS-SF-12 LEFT SModel Orthopedic Support
Identity
- Trade Name
- Spacer Fabric Wrist Splint Sleeve EUDAMEDWrist Splint EUDAMEDSpacer Fabric Wrist Splint EUDAMED
- Device Name
- Wrist Splint/ Wrist sleeve/ Wrist support/Wrist Brace EUDAMEDWrist Brace/Wrist Splint/Wrist Support EUDAMEDORTHOSES EUDAMED
- Model / Reference
- Wrist Splint/ Wrist sleeve/ Wrist support EUDAMEDWS-SF-12 LEFT M EUDAMEDWS-SF-12 RIGHT S EUDAMEDWS-SF-12 RIGHT L EUDAMEDIrufa Wrist Brace/Wrist Splint/Wrist Support EUDAMEDWS-SF-23 LEFT S EUDAMEDWS-SF-12 LEFT XL EUDAMEDOrthopedic Support EUDAMEDWS-SF-12 LEFT S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961660029 EUDAMED04719961660050 EUDAMED04719961660074 EUDAMED04719961660098 EUDAMED04719961660043 EUDAMED04719961660012 EUDAMED
- Basic UDI-DI
- 471996166UPPERTH EUDAMEDB-04719961660098 EUDAMED471996166ORTHOSL 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 471996166UPPERTH | Class I | Active |
| 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 (6)
- EUDAMED 51f0357f-3d5e-4238-bd9d-a8c5499af4ae 61 fields · synced Sep 17, 2026
- EUDAMED ffe8e93b-cabb-4ebe-b294-34956d1e9377 61 fields · synced May 17, 2026
- EUDAMED 2f027366-15c0-4cd4-a5f4-c5178a96deaa 61 fields · synced May 17, 2026
- EUDAMED c917d80b-6411-49bc-997c-4f2827f0208d 61 fields · synced May 18, 2026
- EUDAMED 2cdf6d4f-9b2a-44b6-917f-9b3f3b42e781 61 fields · synced May 18, 2026
- EUDAMED 9e577d03-1c2d-468d-bd27-85efb66579db 61 fields · synced May 18, 2026