NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE

EMDN W02050192

Parent W020501 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS

Registry term list. Not a clinical opinion. 90 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
A1AT Genotyping Test	08437013457705	Progenika Biopharma, S.A.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Amplidiag Analyzer	06430041761204	Mobidiag Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ANDAS Software (Model: ANDAS-HRD)	06959094213046	Amoy Diagnostics Co., LTD.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AnteBC	04745010362019	OÜ Antegenes	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AnteCRC	04745010362026	OÜ Antegenes	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AnteMEL	04745010362033	OÜ Antegenes	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AntePC	04745010362040	OÜ Antegenes	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
BacterioChek® - TB Software	05407007960224	ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
BRCA gene analysis annotation software	05745000468072	BGI EUROPE A/S	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Congenica Rare Disease	03770028804030	SEQONE	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Congenica Rare Disease	50610078000366	Congenica Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
DeepChek® - CMV Software	05407007960231	ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
DeepChek® - HBV Software	05407007960248	ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
DeepChek® - HCV Software	05407007960255	ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
DeepChek® - HIV Software	05407007960262	ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
DeepChek® - HPV Software	05407007960279	ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
DeepChek® - HSV Software	05407007960286	ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
DISQVER	04062996000019	Noscendo GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EMAG® SOFTWARE V1.3	03573026613358	bioMérieux SA	Class A	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EMAG® SOFTWARE V1.4	03573026635046	bioMérieux SA	Class A	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EMAG® v1.2 UPDATE INSTALLER DVD	03573026608613	bioMérieux SA	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EntericBio® C.difficile plug-in	05391513879562	Serosep Limited	Class B	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EntericBio® CPE plug-in	05391513879579	Serosep Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EntericBio® Dx plug-in	05391513879609	Serosep Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EntericBio® Gastro Panel 2 Plug-In	05391513879555	Serosep Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EntericBio® Viral Panel 1 plug-in	05391513879616	Serosep Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EntericBio® Viral Panel 2 plug-in	05391513879623	Serosep Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EntericBio® Viral Panel 3 plug-in	05391513879593	Serosep Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Fetal Chromosome Aneuploidy Analysis Software	06974968583254	GeneMind Biosciences Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
FluoroSoftware® IVD	04049055003822	Hain Lifescience GmbH	Class A	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
FluoroSoftware® XT-IVD	04049055003839	Hain Lifescience GmbH	Class A	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
GeneMind	06974968583261	GeneMind Biosciences Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
GeneMind	06974968584077	GeneMind Biosciences Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
GeneMind	06974968584091	GeneMind Biosciences Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Genesystems© Genebytes	08436566763219	SISTEMAS GENOMICOS S.L.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Genesystems G-NIPT	08436566763196	SISTEMAS GENOMICOS S.L.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Genesystems© – G-PRECON	08436566763202	SISTEMAS GENOMICOS S.L.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Genexpath	03770026953082	Genexpath	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
GenoXtract® fleXT Software	04049055003815	Hain Lifescience GmbH	Class A	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ID HPA XT	08437013457699	Progenika Biopharma, S.A.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
InfectID-Client Software	09309001216023	Microbio Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
iSAFETM Non-Invasive Prenatal Test Data Analysis Software	01240000008784	Atila Biosystems Inc.	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
JuliaOmix CLD	08058898000024	GenomeUp	Class A	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
KRAS Gene Mutation, BMP3/NDRG4 Gene Methylation and FIT Combined Detection Analysis Software	06971980730178	Hangzhou New Horizon Health Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MAP-AD Test Software - Backend	08437026887094	ADmit Therapeutics	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MAP-AD Test Software - Frontend	08437026887100	ADmit Therapeutics	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MAP-AD Test Software - Frontend	08437026887117	ADmit Therapeutics	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MAP-AD Test Software - Frontend	08437026887124	ADmit Therapeutics	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MH Guide	04260563550268	Molecular Health GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MH Guide	04260563550275	Molecular Health GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED