GENEDIA Multi Influenza Ag Rapid Test Kit

EUDAMED

Class IVD General (EU MDR)

Ref 152GS10

by GC Medical Science Corporation

Identity

Trade Name: GENEDIA Multi Influenza Ag Rapid Test Kit EUDAMED
Device Name: GENEDIA Multi Influenza Ag Rapid Test Kit EUDAMED
Model / Reference: 152GS10 EUDAMED

Identifiers

Primary DI / UDI-DI: 08806134615217 EUDAMED
Basic UDI-DI: B-08806134615217 EUDAMED
EMDN Code: W0105099004 INFLUENZA A AND /OR B - RT & POC EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

GENEDIA Multi Influenza Ag Rapid Test Kit by GC Medical Science Corporation — 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-08806134615217	Class IVD General	Active

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Manufacturer

Manufacturer: GC Medical Science Corporation
EUDAMED SRN: KR-MF-000015840
Authorised Representative: Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (1)

EUDAMED 003ad1e6-ef89-455e-bc32-44ea7c1cd6b2 61 fields · synced Jul 13, 2026