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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 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

QuantStudio™ 7 Pro Dx Real‑Time PCR Instrument

QuantStudio™ 7 Pro Dx Real-Time PCR Instrument and Accessories

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302016148
Basic UDI-DI: 0190302TCF00005354P
Reference: A50745
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

SeqStudio™ Flex Dx series 96-Well Standard Retainer & Base Set

96 Well Standard Retainer and Base Set, 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: 10190302015738
Basic UDI-DI: 0190302A55961TF
Reference: A55961
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 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

SeqStudio™ 8 Flex Dx Capillary Array 50 cm

Capillary Array 50 cm, 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: 10190302015714
Basic UDI-DI: 0190302A49944TY
Reference: A49944
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 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

QuantStudio™ 5 Dx Real‑Time PCR Instrument (96-Well 0.2ml Block)

QuantStudio™ 5 Dx Real-Time PCR System and Accessories

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302015592
Basic UDI-DI: 0190302A47326SJ
Reference: A47324 (A47326, A47327)
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

3500 Dx Series 384-Well Septa

8-Strip/384-Well Septa, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302007375
Basic UDI-DI: 019030244106079M
Reference: 4410607
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

3500 Dx Series 8-Tube Standard Retainer & Base Set

8-Tube Standard Retainer and Base Set, 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: 10190302007344
Basic UDI-DI: 019030244102308U
Reference: 4410230
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

GeneScan™ 600 LIZ™ Size Standard v2.0 Dx

GeneScan Size Standard, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302007092
Basic UDI-DI: 0190302A25794SK
Reference: A25794
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

DS-33 GeneScan™ Install Kit Dx with GeneScan™ 600 LIZ™ v2.0

GeneScan Standard, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302007085
Basic UDI-DI: 0190302A25793SH
Reference: A25793
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

DS-30 Matrix Standard Kit (Dye Set D) Dx

Matrix Standards, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302006637
Basic UDI-DI: 0190302A35945ST
Reference: A35945
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

3500 Dx Genetic Analyzer

Applied Biosystems™ 3500 Dx/3500xL Dx Genetic Analyzers

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302005937
Basic UDI-DI: 0190302TCF00005084L
Reference: 4405182 (A27772)
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Ion PGM™ Dx Sequencer

Ion Personal Genome Machine (PGM™) Dx Instrument System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000833
Basic UDI-DI: 0190302A25511RB
Reference: 4485656
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Polymer Pouch Caps, Dx

Polymer Pouch Cap, 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: 10190302000680
Basic UDI-DI: 01903024462785CK
Reference: 4462785
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Sequencing Standard BigDye™ Terminator v1.1 Dx

Sequencing Standard, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000673
Basic UDI-DI: 01903024462113AU
Reference: 4462113
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Polymer Delivery Pump Cleaning Kit Dx

Polymer Delivery Pump Cleaning Kit Dx, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000666
Basic UDI-DI: 0190302TCF00005034A
Reference: 4461875
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Array Card Spectral Calibration Dye Kit

Array Card Kits, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000444
Basic UDI-DI: 0190302TCF0000576DAR
Reference: 4432644
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

384‑Well Region of Interest (ROI) and Background Plates

Region of Interest (ROI) and Background Plates, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000314
Basic UDI-DI: 0190302TCF0000576AAK
Reference: 4432482
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details