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    <tradeName>KMRengine® Premium Entry (5 years)</tradeName>
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    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
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    <tradeName>KMRengine® Standard Extension (+1 year)</tradeName>
    <deviceName>KMRengine® Standard Extension (+1 year)</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <udiDi>D-48496513V</udiDi>
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    <tradeName>KMRengine® Premium Extension (+5 years)</tradeName>
    <deviceName>KMRengine® Premium Extension (+5 years)</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
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    <udiDi>D-442835PY</udiDi>
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    <tradeName>SYNCHRON UDR Kit (12-pack)</tradeName>
    <deviceName>SYNCHRON UDR Kit (12-pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442835</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:19.597Z</lastUpdated>
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    <udiDi>18800076500508</udiDi>
    <basicUdiDi>88000765PREP1PX</basicUdiDi>
    <tradeName>GT NUCLEIC ACID PREP KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genomictree, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000037890</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT-PREP-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T09:06:37.965Z</lastUpdated>
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    <udiDi>10190302017763</udiDi>
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    <tradeName>Oncomine™ Dx Target Test User Guides and Assay Definition File</tradeName>
    <deviceName>Oncomine™ Dx Target Test User Guides and Assay Definition File, a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A52639 (A49756)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:40:20.300Z</lastUpdated>
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    <udiDi>09309001216023</udiDi>
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    <tradeName>InfectID-Client Software</tradeName>
    <deviceName>InfectID-Client Software</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V1.1</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:37:54.657Z</lastUpdated>
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    <udiDi>00816270020811</udiDi>
    <basicUdiDi>0081627002NEXTSEQAD</basicUdiDi>
    <tradeName>Illumina DRAGEN® Server for NextSeq550Dx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20086130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:47.731Z</lastUpdated>
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    <tradeName>Sentosa ST401i</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400124</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:19.830Z</lastUpdated>
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    <tradeName>Sentosa ST401e</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:19.806Z</lastUpdated>
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    <udiDi>08885013956207</udiDi>
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    <tradeName>Sentosa ST Template Kit (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>690006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:18.538Z</lastUpdated>
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    <udiDi>08885013956252</udiDi>
    <basicUdiDi>888501395SSQ301P2E</basicUdiDi>
    <tradeName>Sentosa SQ Sequencing Kit (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>690004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:18.516Z</lastUpdated>
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    <udiDi>08885013956290</udiDi>
    <basicUdiDi>888501395SSQ301P2E</basicUdiDi>
    <tradeName>Sentosa SQ 318 Chip Kit (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:18.491Z</lastUpdated>
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    <tradeName>Genesystems© Genebytes</tradeName>
    <deviceName>Genesystems© Genebytes</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4827</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:29.547Z</lastUpdated>
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    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <tradeName>Genesystems G-NIPT</tradeName>
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    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
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    <tradeName>DTstream 9L4</tradeName>
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    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
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