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208 device results listed.

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Diomni™ Software V4.3.1

Diomni™ Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302020046
Basic UDI-DI: 0190302TCF00005384V
Reference: A40007355
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 30.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

CytoScan Dx Array, 6 pk

CytoScan Dx Assay, a part of CytoScan™ Dx Test

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Affymetrix, Inc.
Manufacturer SRN: US-MF-000028847
UDI-DI: 00856826006098
Basic UDI-DI: 0856826006902420G9
Reference: 902150 (902420)
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

Chromosome Analysis Suite Dx Software (ChAS Dx)

Chromosome Analysis Suite Dx Software (ChAS Dx), a part of CytoScan™ Dx Test

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Affymetrix, Inc.
Manufacturer SRN: US-MF-000028847
UDI-DI: 00856826006210
Basic UDI-DI: 0856826006610525FE
Reference: 610525
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

GeneChip™ Fluidics Station FS450Dx v.2

GeneChip™ System 3000Dx v.2 Instrument System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Affymetrix, Inc.
Manufacturer SRN: US-MF-000028847
UDI-DI: 00856826006029
Basic UDI-DI: 0856826006000334CC
Reference: 00-0335 (00-0334)
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

CBC Wash Septa Clip Dx

CBC Wash Septa Clip, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302019736
Basic UDI-DI: 0190302A66359TG
Reference: A66359
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Target Test (DNA and RNA Panel)

Oncomine™ Dx Target Test

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302019620
Basic UDI-DI: 0190302A49756TV
Reference: A65534 （A65538)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

KingFisher™ Apex Dx Purification Instrument

KingFisher™ Apex Dx Purification Instrument and Accessories

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302019231
Basic UDI-DI: 0190302TCF00005434N
Reference: B5400900P (B5400910, B5400920, B5400930, B5400940)
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ COVID 19, Flu A, Flu B, RSV Select Assay

TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

IVD Class BIVDR 2017/746Not intended for EU marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302019064
Basic UDI-DI: 0190302A56125SA
Reference: A56430 (A56125)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

VeritiPro™ Dx Thermal Cycler

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302018944
Basic UDI-DI: 0190302TCF00005634U
Reference: A55826
EMDN: W02039006
EMDN description: DNA THERMAL CYCLERS
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Applied Biosystems™ SeqStudio™ 8 Flex Dx Genetic Analyzer

Applied Biosystems™ SeqStudio™ Flex Dx Series Genetic Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302018838
Basic UDI-DI: 0190302A50534RM
Reference: A50534
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Target Test User Guides and Assay Definition File

A54452

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302018333
Basic UDI-DI: 0190302A54452SE
Reference: A54452 (A65538)
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Diomni™ Software V3.1.0

Diomni™ Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302018135
Basic UDI-DI: 0190302TCF00005384V
Reference: A54762 (A56307)
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Ion Torrent™ Genexus™ Dx Purification System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302017800
Basic UDI-DI: 0190302A53257S7
Reference: A53257 (A53580)
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Ion Torrent™ Genexus™ Dx Integrated Sequencer

Ion Torrent™ Genexus™ Dx Integrated Sequencer System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302017794
Basic UDI-DI: 0190302A53579SY
Reference: A53256 (A53579)
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Genexus™ Dx Purification Supplies 2

Genexus™ Dx Purification Supplies 2, a part of Ion Torrent™ Genexus™ Dx FFPE DNA/RNA Purification Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017640
Basic UDI-DI: 0190302A51081RC
Reference: A51081 (A52170)
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Genexus™ Dx Purification Supplies 1

Genexus™ Dx Purification Supplies 1, a part of Ion Torrent™ Genexus™ Dx cfTNA Purification Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017633
Basic UDI-DI: 0190302A51080RA
Reference: A51080 (A52171)
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Genexus™ Dx Nucleic Acid Quantitation

Genexus™ Dx Nucleic Acid Quantitation, a part of Ion Torrent™ Genexus™ Dx FFPE DNA/RNA and cfTNA Purification Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017626
Basic UDI-DI: 0190302A51078RP
Reference: A51078 (A52170, A52171)
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Genexus™ Dx Cell-Free Total Nucleic Acid Purification

Genexus™ Dx Cell-Free Total Nucleic Acid Purification, a part of Ion Torrent™ Genexus™ Dx cfTNA Purification Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017619
Basic UDI-DI: 0190302A51077RM
Reference: A51077 (A52171)
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Genexus™ Dx FFPE DNA and RNA Purification

Genexus™ Dx FFPE DNA and RNA Purification, a part of Ion Torrent™ Genexus™ Dx FFPE DNA/RNA Purification Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017602
Basic UDI-DI: 0190302A51076RK
Reference: A51076 (A52170)
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Ion Torrent™ Genexus™ Dx Conical Bottles

Ion Torrent™ Genexus™ Dx Conical Bottles ,a part of Ion Genexus™ Dx Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017589
Basic UDI-DI: 0190302A50869SP
Reference: A50869
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details