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FIAPro™ Mobile Immunofluorescence Analyzer
EUDAMEDClass A (EU MDR)
Ref VMFIA1003
Identity
- Trade Name
- FIAPro™ Mobile Immunofluorescence Analyzer EUDAMED
- Device Name
- Mobile Immunofluorescence Analyzer EUDAMED
- Model / Reference
- VMFIA1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548252623 EUDAMED
- Basic UDI-DI
- 868354825FIAProMobilXJ EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
FIAPro™ Mobile Immunofluorescence Analyzer by Vitrosens Biotechnology Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 868354825FIAProMobilXJ | Class A | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 1fd48c7d-8a09-4f9e-bc57-711442fc073d 61 fields · synced Jul 9, 2026