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71 device results listed.

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Whole Genome Copy Number Variation Analysis Software

CNV-SEQ_analysis

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583278
Basic UDI-DI: B-06974968583278
Reference: I000005
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

GeneMind

PGTA_analysis

IVD generalIVDDOn the marketProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583261
Basic UDI-DI: B-06974968583261
Reference: I000004
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Analysis Software

NIPT_analysis

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583254
Basic UDI-DI: B-06974968583254
Reference: I000003
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Genexpath

RT-MIS

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953082
Basic UDI-DI: B-03770026953082
Reference: RT-MIS
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

Manufacturer products View details

MICK Clinical

MICKCLI_001

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Sequentia Biotech SL
Manufacturer SRN: ES-MF-000044278
UDI-DI: 08437028000019
Basic UDI-DI: 843702800029122310001GT
Reference: MICKCLI_001
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:17

Manufacturer products View details

07290020318008

PCR-AI-01

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: AZURE VAULT LTD
Manufacturer SRN: IL-MF-000047316
UDI-DI: 07290020318008
Basic UDI-DI: 7290020318AIB4
Reference: PCR-AI-01
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

06971980730178

akbbnf01 for windows

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou New Horizon Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027517
UDI-DI: 06971980730178
Basic UDI-DI: 697198037017MR
Reference: /
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

FluoroSoftware® XT-IVD

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003839
Basic UDI-DI: 40490550300001091UL
Reference: 1897070
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

FluoroSoftware® IVD

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003822
Basic UDI-DI: 40490550300001090UJ
Reference: 1897069
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

GenoXtract® fleXT Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003815
Basic UDI-DI: 40490550300001089UZ
Reference: 1896938
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

03770028804030

Congenica Rare Disease

IVD Class CIVDR 2017/746On the marketDirect marking

Manufacturer: SEQONE
Manufacturer SRN: FR-MF-000028525
UDI-DI: 03770028804030
Basic UDI-DI: 3770028804CRD6G
Reference: CRD
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 16:09

Manufacturer products View details

03770028804023

Variant LifePipe

IVD Class CIVDR 2017/746On the marketDirect marking

Manufacturer: SEQONE
Manufacturer SRN: FR-MF-000028525
UDI-DI: 03770028804023
Basic UDI-DI: 3770028804VLP9M
Reference: VLP
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:09

Manufacturer products View details

Ziwig Endotest

Endotest Diagnostic

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Ziwig
Manufacturer SRN: FR-MF-000024009
UDI-DI: 03770025060026
Basic UDI-DI: 3770025060ED100JB
Reference: ED100
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:06

Manufacturer products View details

MAP-AD Test Software - Frontend

MAP-AD Test Software

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: ADmit Therapeutics
Manufacturer SRN: ES-MF-000042518
UDI-DI: 08437026887124
Basic UDI-DI: 8437026887AD002YK
Reference: AD002
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:37

Manufacturer products View details

MAP-AD Test Software - Frontend

MAP-AD Test Software

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: ADmit Therapeutics
Manufacturer SRN: ES-MF-000042518
UDI-DI: 08437026887117
Basic UDI-DI: 8437026887AD002YK
Reference: AD002
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:37

Manufacturer products View details

MAP-AD Test Software - Frontend

MAP-AD Test Software

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: ADmit Therapeutics
Manufacturer SRN: ES-MF-000042518
UDI-DI: 08437026887100
Basic UDI-DI: 8437026887AD002YK
Reference: AD002
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:37

Manufacturer products View details

MAP-AD Test Software - Backend

MAP-AD Test Software

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: ADmit Therapeutics
Manufacturer SRN: ES-MF-000042518
UDI-DI: 08437026887094
Basic UDI-DI: 8437026887AD002YK
Reference: AD002
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:37

Manufacturer products View details

A1AT Genotyping Test

A1AT Genotyping Test ANALYSIS SOFTWARE

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457705
Basic UDI-DI: 8437013457Gentest004QR
Reference: 1292320000/1292380000
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

ID HPA XT

ID HPA XT ANALYSIS SOFTWARE

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457699
Basic UDI-DI: 8437013457Gentest003QP
Reference: 1010220034
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

Amplidiag Analyzer

IVD generalNot specifiedNo longer on the market

Manufacturer: Mobidiag Ltd.
Manufacturer SRN: FI-MF-000001215
UDI-DI: 06430041761204
Basic UDI-DI: B-06430041761204
Reference: AD-ASW
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 10:32

Manufacturer products View details