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Finger Sleeve/ Finger support/Finger Brace
EUDAMEDClass I (EU MDR)
Ref FS-OS-31 MModel Fingers orthoses/Finger Splint/ Finger support/Finger Brace
Identity
- Trade Name
- Finger Sleeve/ Finger support/Finger Brace EUDAMED
- Device Name
- Finger Splint/ Finger support/Finger Brace EUDAMED
- Model / Reference
- Fingers orthoses/Finger Splint/ Finger support/Finger Brace EUDAMEDFS-OS-31 M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961660913 EUDAMED
- Basic UDI-DI
- 471996166FINGERNX EUDAMED
- EMDN Code
- Y060603 FINGERS 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
Finger Sleeve/ Finger support/Finger Brace 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 | 471996166FINGERNX | 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 9af7da87-764d-4b13-a9c5-cc452e5e1e24 61 fields · synced Jun 19, 2026