Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA)

EUDAMED

Class IVD General (EU MDR)

Ref FCFLU(AH5)-502a

by Healgen Scientific Limited Liability Company

Identity

Trade Name: Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) EUDAMED
Model / Reference: FCFLU(AH5)-502a EUDAMED

Identifiers

Primary DI / UDI-DI: D-FCFLU(AH5)-502aHGHC EUDAMED
Basic UDI-DI: B-FCFLU(AH5)-502aHGHC EUDAMED
EMDN Code: W0105040604 INFLUENZA & PARA INFLUENZA EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

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

Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) by Healgen Scientific Limited Liability Company — Class IVD General — IVDD — listed in EUDAMED

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-FCFLU(AH5)-502aHGHC	Class IVD General	Active

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Manufacturer

Manufacturer: Healgen Scientific Limited Liability Company
EUDAMED SRN: US-MF-000018839
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

EUDAMED 01d83a58-aa46-471c-aa75-5db5f4b285c3 61 fields · synced Oct 6, 2026