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    <tradeName>PredicineCARE Assay</tradeName>
    <deviceName>PredicineCARE™ Assay</deviceName>
    <manufacturerName>Predicine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000031888</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD-CA9999KE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:55:10.888Z</lastUpdated>
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    <tradeName>CytoScan Dx Array, 6 pk</tradeName>
    <deviceName>CytoScan Dx Assay, a part of CytoScan™ Dx Test</deviceName>
    <manufacturerName>Affymetrix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000028847</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
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    <reference>902150 (902420)</reference>
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    <lastUpdated>2026-07-16T03:41:39.997Z</lastUpdated>
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    <tradeName>Oncotype DX Breast Recurrence Score® Computational Software</tradeName>
    <deviceName>Oncotype DX Breast Recurrence Score® Test</deviceName>
    <manufacturerName>Genomic Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018730</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <tradeName>clonoSEQ Assay B-Cell Reagent Set</tradeName>
    <deviceName>clonoSEQ Assay B-Cell Reagent Set</deviceName>
    <manufacturerName>Adaptive Biotechnologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029850</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A040</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:20:15.876Z</lastUpdated>
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    <basicUdiDi>0850017493A011248A</basicUdiDi>
    <tradeName>AmplideX Fragile X Dx &amp; Carrier Screen Kit</tradeName>
    <deviceName>AmplideX Fragile X Dx &amp; Carrier Screen Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A01124</reference>
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    <lastUpdated>2026-07-16T03:15:37.531Z</lastUpdated>
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    <udiDi>00810119550149</udiDi>
    <basicUdiDi>081011955TPEDxPA7</basicUdiDi>
    <tradeName>Twist Precision Exome Dx Panel, 2 reactions</tradeName>
    <deviceName>Twist Precision Exome Dx Panel</deviceName>
    <manufacturerName>Twist Bioscience Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000039181</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001599</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107619</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:54:18.284Z</lastUpdated>
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    <basicUdiDi>081011955TPPEDxKLE</basicUdiDi>
    <tradeName>Twist Precision Prep and Enrichment Dx Kit, 16 samples - Box 1</tradeName>
    <deviceName>Twist Precision Prep and Enrichment Dx Kit</deviceName>
    <manufacturerName>Twist Bioscience Corporation</manufacturerName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:54:16.694Z</lastUpdated>
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    <basicUdiDi>081011955TPEDxK9V</basicUdiDi>
    <tradeName>Twist Precision Exome Dx Kit, 96 samples (A) - Box 1</tradeName>
    <deviceName>Twist Precision Exome Dx Kit</deviceName>
    <manufacturerName>Twist Bioscience Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000039181</manufacturerSrn>
    <authorisedRepresentativeName>QAdvis EAR AB</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104993</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:54:15.919Z</lastUpdated>
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    <tradeName>Universal Sequencing Reaction Kit T1+ FCL SE100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002764-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:47.531Z</lastUpdated>
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    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCS PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-003025-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:47.430Z</lastUpdated>
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    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCS PE150</tradeName>
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    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-003025-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:41.229Z</lastUpdated>
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    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCS SE100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-003026-00</reference>
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    <lastUpdated>2026-07-15T20:02:41.102Z</lastUpdated>
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    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCS SE100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-003026-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:40.723Z</lastUpdated>
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    <tradeName>Oncomine™ Dx Target Test (DNA and RNA Panel)</tradeName>
    <deviceName>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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A65534 （A65538)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:51:01.346Z</lastUpdated>
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    <tradeName>Genexus™ Dx Purification Supplies 2</tradeName>
    <deviceName>Genexus™ Dx Purification Supplies 2, a part of Ion Torrent™ Genexus™ Dx FFPE DNA/RNA Purification Kit</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51081 (A52170)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:42.822Z</lastUpdated>
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    <tradeName>Genexus™ Dx Purification Supplies 1</tradeName>
    <deviceName>Genexus™ Dx Purification Supplies 1, a part of Ion Torrent™ Genexus™ Dx cfTNA Purification Kit</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51080 (A52171)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:41.234Z</lastUpdated>
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    <tradeName>Genexus™ Dx Nucleic Acid Quantitation</tradeName>
    <deviceName>Genexus™ Dx Nucleic Acid Quantitation, a part of Ion Torrent™ Genexus™ Dx FFPE DNA/RNA and cfTNA Purification Kit</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51078 (A52170, A52171)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:38.821Z</lastUpdated>
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    <tradeName>Genexus™ Dx Cell-Free Total Nucleic Acid Purification</tradeName>
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    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51077 (A52171)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:37.223Z</lastUpdated>
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    <tradeName>Genexus™ Dx FFPE DNA and RNA Purification</tradeName>
    <deviceName>Genexus™ Dx FFPE DNA and RNA Purification, a part of Ion Torrent™ Genexus™ Dx FFPE DNA/RNA Purification Kit</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51076 (A52170)</reference>
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    <lastUpdated>2026-07-15T19:50:36.426Z</lastUpdated>
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    <tradeName>Ion Torrent™ Genexus™ Dx Conical Bottles</tradeName>
    <deviceName>Ion Torrent™ Genexus™ Dx Conical Bottles ,a part of Ion Genexus™ Dx Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50869</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:34.820Z</lastUpdated>
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