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    <tradeName>Diomni™ Software V3.1.0</tradeName>
    <deviceName>Diomni™ Software</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A54762 (A56307)</reference>
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    <tradeName>Ion Torrent™ Genexus™ Dx Integrated Sequencer</tradeName>
    <deviceName>Ion Torrent™ Genexus™ Dx Integrated Sequencer System</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
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    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A53256 (A53579)</reference>
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    <tradeName>QuantStudio™ 7 Pro Dx Real‑Time PCR Instrument</tradeName>
    <deviceName>QuantStudio™ 7 Pro Dx Real-Time PCR Instrument and Accessories</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
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    <tradeName>SeqStudio™ Flex Dx series 96-Well Standard Retainer &amp; Base Set</tradeName>
    <deviceName>96 Well Standard Retainer and Base Set, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A55961</reference>
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    <lastUpdated>2026-07-15T19:50:05.059Z</lastUpdated>
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    <basicUdiDi>0190302A49944TY</basicUdiDi>
    <tradeName>SeqStudio™ 8 Flex Dx Capillary Array 50 cm</tradeName>
    <deviceName>Capillary Array 50 cm, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A49944</reference>
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    <basicUdiDi>0190302A47326SJ</basicUdiDi>
    <tradeName>QuantStudio™ 5 Dx Real‑Time PCR Instrument (96-Well 0.2ml Block)</tradeName>
    <deviceName>QuantStudio™ 5 Dx Real-Time PCR System and Accessories</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A47324 (A47326, A47327)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:03.457Z</lastUpdated>
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    <basicUdiDi>019030244106079M</basicUdiDi>
    <tradeName>3500 Dx Series 384-Well Septa</tradeName>
    <deviceName>8-Strip/384-Well Septa, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4410607</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:59.456Z</lastUpdated>
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    <basicUdiDi>019030244102308U</basicUdiDi>
    <tradeName>3500 Dx Series 8-Tube Standard Retainer &amp; Base Set</tradeName>
    <deviceName>8-Tube Standard Retainer and Base Set, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4410230</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:58.656Z</lastUpdated>
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    <udiDi>10190302007092</udiDi>
    <basicUdiDi>0190302A25794SK</basicUdiDi>
    <tradeName>GeneScan™ 600 LIZ™ Size Standard v2.0 Dx</tradeName>
    <deviceName>GeneScan Size Standard, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A25794</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:57.863Z</lastUpdated>
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    <udiDi>10190302007085</udiDi>
    <basicUdiDi>0190302A25793SH</basicUdiDi>
    <tradeName>DS-33 GeneScan™ Install Kit Dx with GeneScan™ 600 LIZ™ v2.0</tradeName>
    <deviceName>GeneScan Standard, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A25793</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:57.058Z</lastUpdated>
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    <udiDi>10190302006637</udiDi>
    <basicUdiDi>0190302A35945ST</basicUdiDi>
    <tradeName>DS-30 Matrix Standard Kit (Dye Set D) Dx</tradeName>
    <deviceName>Matrix Standards, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A35945</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:52.250Z</lastUpdated>
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    <udiDi>10190302005937</udiDi>
    <basicUdiDi>0190302TCF00005084L</basicUdiDi>
    <tradeName>3500 Dx Genetic Analyzer</tradeName>
    <deviceName>Applied Biosystems™ 3500 Dx/3500xL Dx Genetic Analyzers</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4405182 (A27772)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:49.889Z</lastUpdated>
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    <udiDi>10190302000833</udiDi>
    <basicUdiDi>0190302A25511RB</basicUdiDi>
    <tradeName>Ion PGM™ Dx Sequencer</tradeName>
    <deviceName>Ion Personal Genome Machine (PGM™) Dx Instrument System</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4485656</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:38.650Z</lastUpdated>
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    <udiDi>10190302000680</udiDi>
    <basicUdiDi>01903024462785CK</basicUdiDi>
    <tradeName>Polymer Pouch Caps, Dx</tradeName>
    <deviceName>Polymer Pouch Cap, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4462785</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:37.848Z</lastUpdated>
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    <udiDi>10190302000673</udiDi>
    <basicUdiDi>01903024462113AU</basicUdiDi>
    <tradeName>Sequencing Standard BigDye™ Terminator v1.1 Dx</tradeName>
    <deviceName>Sequencing Standard, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4462113</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:37.051Z</lastUpdated>
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    <udiDi>10190302000666</udiDi>
    <basicUdiDi>0190302TCF00005034A</basicUdiDi>
    <tradeName>Polymer Delivery Pump Cleaning Kit Dx</tradeName>
    <deviceName>Polymer Delivery Pump Cleaning Kit Dx, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
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    <reference>4461875</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:36.250Z</lastUpdated>
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    <basicUdiDi>0190302TCF0000576DAR</basicUdiDi>
    <tradeName>Array Card Spectral Calibration Dye Kit</tradeName>
    <deviceName>Array Card Kits, a part of Calibration and Verification Plates</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4432644</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:32.251Z</lastUpdated>
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    <basicUdiDi>0190302TCF0000576AAK</basicUdiDi>
    <tradeName>384‑Well Region of Interest (ROI) and Background Plates</tradeName>
    <deviceName>Region of Interest (ROI) and Background Plates, a part of Calibration and Verification Plates</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4432482</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:31.446Z</lastUpdated>
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    <basicUdiDi>0190302TCF0000576BAM</basicUdiDi>
    <tradeName>384-Well Spectral Calibration Plate with FAM Dye</tradeName>
    <deviceName>Spectral Calibration Plates, a part of Calibration and Verification Plates</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4432445</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:30.646Z</lastUpdated>
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    <tradeName>RNase P 384-Well Instrument Verification Plate</tradeName>
    <deviceName>RNase P Instrument Verification Plates, a part of Calibration and Verification Plates</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4432500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:29.052Z</lastUpdated>
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