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Finger Sleeve/ Finger support/Finger Brace
EUDAMEDClass I (EU MDR)
Ref FS-OS-31 LModel Fingers orthoses/Finger Splint/ Finger support/Finger BraceRef FS-OS-12Ref FS-OS-31 SRef FS-OS-31 XL
Identity
- Trade Name
- Finger Sleeve/ Finger support/Finger Brace EUDAMEDFinger Splint/ 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 L EUDAMEDFS-OS-12 EUDAMEDFS-OS-31 S EUDAMEDFS-OS-31 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961660920 EUDAMED04719961660883 EUDAMED04719961660906 EUDAMED04719961660937 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 (4)
- EUDAMED 16a832ad-e772-42af-98fd-13d3610017e9 61 fields · synced Jul 24, 2026
- EUDAMED a6bc9f81-0035-4f11-8a45-973ff80a56e9 61 fields · synced May 17, 2026
- EUDAMED 2822b027-bc6d-4e1e-84fb-e0d273b6bf12 61 fields · synced May 18, 2026
- EUDAMED 917f92e2-8103-4521-8da1-9906b7be316d 61 fields · synced May 18, 2026