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IIFT: Flavivirus Mosaic 1 (IgM)

EUDAMED

Class IVD General (EU MDR)

Ref FI 2661-1010-1 MModel FI 2661-1 M

by EUROIMMUN Medizinische Labordiagnostika AG

Identity

Trade Name
IIFT: Flavivirus Mosaic 1 (IgM) EUDAMED
Device Name
IIFT: Flavivirus Mosaic 1 (IgM) EUDAMED
Model / Reference
FI 2661-1 M EUDAMED
FI 2661-1010-1 M EUDAMED

Identifiers

Primary DI / UDI-DI
04049016058007 EUDAMED
Basic UDI-DI
B-04049016058007 EUDAMED
EMDN Code
W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

IIFT: Flavivirus Mosaic 1 (IgM) by EUROIMMUN Medizinische Labordiagnostika AG — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
DE-MF-000005296

Sources (1)

  • EUDAMED a627e7c4-afb8-4608-b260-37fe27db5a61 61 fields · synced Oct 7, 2026