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FIAPro™ Automatic Immunofluorescence Analyzer

EUDAMED

Class A (EU MDR)

Ref VMFIA1005Model VMFIA05

by Vitrosens Biotechnology Inc.

Identity

Trade Name
FIAPro™ Automatic Immunofluorescence Analyzer EUDAMED
Device Name
Automatic Immunofluorescence Analyzer EUDAMED
Model / Reference
VMFIA05 EUDAMED
VMFIA1005 EUDAMED

Identifiers

Primary DI / UDI-DI
08685214526991 EUDAMED
Basic UDI-DI
868521452VMFIA05WP EUDAMED
Direct Marketing DI
08685214526991 EUDAMED
EMDN Code
W0201020201 IMMUNOCHEMISTRY READERS 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

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

FIAPro™ Automatic 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

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Manufacturer

EUDAMED SRN
TR-MF-000026452

Sources (1)

  • EUDAMED 11c2496d-4b3b-462f-a28d-bec98be7fae6 61 fields · synced Jul 16, 2026