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Uniogen Oy

Finland·FI-MF-000032341

Last updated June 8, 2026

Information

Device	Model / Reference	Registries	Class	Status
GenomEra® C. difficile Assay Kit	CDX-40-01-40	EUDAMED	IVD General	Active
GenomEra GBS Assay Kit	CDX-60-01-20	EUDAMED	IVD General	Active
GenomEra SARS-CoV-2 Assay Kit	CDX-130-01-100	EUDAMED	IVD General	Active
GenomEra MRSA/SA AC Assay Kit	CDX-30-05-20	EUDAMED	IVD General	Active
GenomEra Norovirus Assay kit	CDX-100-01-20	EUDAMED	IVD General	Active
GenomEra MRSA/SA Multi Swab Assay Kit	CDX-30-02-20	EUDAMED	IVD General	Active
GenomEra S. pneumoniae Assay Kit	CDX-70-01-40	EUDAMED	IVD General	Active
GenomEra SARS-CoV-2 2.0 Assay Kit	CDX-150-01-100	EUDAMED	IVD General	Active
GenomEra C. difficile Assay Kit	CDX-40-02-40	EUDAMED	IVD General	Active
GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit	CDX-140-01-20	EUDAMED	IVD General	Active
GenomEra Norovirus Assay kit	CDX-100-01-40	EUDAMED	IVD General	Active
GenomEra SARS-CoV-2 2.0 Assay Kit	CDX-150-01-20	EUDAMED	IVD General	Active
GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit	CDX-160-01-100	EUDAMED	IVD General	Active
GenomEra SARS-CoV-2 Assay Kit	CDX-130-01-20	EUDAMED	IVD General	Active
GenomEra CDX System	CDX-10-020	EUDAMED	Class A	Active
GenomEra CDX Software	CDX-10-031	EUDAMED	Class A	Active
GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit	CDX-140-01-100	EUDAMED	IVD General	Active
GenomEra GBS Assay Kit	CDX-60-01-40	EUDAMED	IVD General	Active
GenomEra HSV 1/2, VZV + EV Assay Kit	CDX-170-01-20	EUDAMED	IVD General	Active
GenomEra MRSA/SA AC Assay Kit	CDX-30-05-40	EUDAMED	IVD General	Active
GenomEra S. pneumoniae Assay Kit	CDX-70-01-20	EUDAMED	IVD General	Active

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