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<eudamedExport entity="devices">
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    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <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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    <udiDi>06975996270451</udiDi>
    <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>
    <emdnCode>W010699</emdnCode>
    <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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    <udiDi>06975996270437</udiDi>
    <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>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-003025-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:41.229Z</lastUpdated>
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    <udiDi>06975996270468</udiDi>
    <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>2026-07-15T20:02:41.102Z</lastUpdated>
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    <udiDi>06975996270444</udiDi>
    <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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  <row>
    <udiDi>10190302019620</udiDi>
    <basicUdiDi>0190302A49756TV</basicUdiDi>
    <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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    <udiDi>10190302017640</udiDi>
    <basicUdiDi>0190302A51081RC</basicUdiDi>
    <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>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <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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  <row>
    <udiDi>10190302017633</udiDi>
    <basicUdiDi>0190302A51080RA</basicUdiDi>
    <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>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <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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  <row>
    <udiDi>10190302017626</udiDi>
    <basicUdiDi>0190302A51078RP</basicUdiDi>
    <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>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <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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  <row>
    <udiDi>10190302017619</udiDi>
    <basicUdiDi>0190302A51077RM</basicUdiDi>
    <tradeName>Genexus™ Dx Cell-Free Total Nucleic Acid Purification</tradeName>
    <deviceName>Genexus™ Dx Cell-Free Total Nucleic Acid Purification, a part of Ion Torrent™ Genexus™ Dx cfTNA Purification Kit</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <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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  <row>
    <udiDi>10190302017602</udiDi>
    <basicUdiDi>0190302A51076RK</basicUdiDi>
    <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>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51076 (A52170)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:36.426Z</lastUpdated>
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  <row>
    <udiDi>10190302017589</udiDi>
    <basicUdiDi>0190302A50869SP</basicUdiDi>
    <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>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <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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  <row>
    <udiDi>10190302017558</udiDi>
    <basicUdiDi>0190302A54104RL</basicUdiDi>
    <tradeName>Ion Torrent™ Genexus™ Dx Barcodes 1-32 HD</tradeName>
    <deviceName>Ion Torrent™ Genexus™ Dx Barcodes 1-32 HD, a part of Ion Genexus™ Dx Reagents and Consumables</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50410 (A54104)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:32.461Z</lastUpdated>
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  <row>
    <udiDi>10190302017572</udiDi>
    <basicUdiDi>0190302A50868SM</basicUdiDi>
    <tradeName>Ion Torrent™ Genexus™ Dx Filter</tradeName>
    <deviceName>Ion Torrent™ Genexus™ Dx Filter, a part of Ion Genexus™ Dx Reagents and Consumables</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50868</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:30.032Z</lastUpdated>
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  <row>
    <udiDi>10190302017565</udiDi>
    <basicUdiDi>0190302A54105RN</basicUdiDi>
    <tradeName>Ion Torrent™ Genexus™ Dx Pipette Tips</tradeName>
    <deviceName>Ion Torrent™ Genexus™ Dx Pipette Tips, a part of Ion Genexus™ Dx Reagents and Consumables</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50426 (A54105)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:29.324Z</lastUpdated>
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  <row>
    <udiDi>10190302017527</udiDi>
    <basicUdiDi>0190302A50432RC</basicUdiDi>
    <tradeName>Genexus™ Dx Cartridge</tradeName>
    <deviceName>Ion Torrent™ Genexus™ Dx Sequencing Kit, a part of Ion Genexus™ Dx Reagents and Consumables</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50865 (A50432)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:13.064Z</lastUpdated>
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  <row>
    <udiDi>10190302017510</udiDi>
    <basicUdiDi>0190302A54106RQ</basicUdiDi>
    <tradeName>Ion Torrent™ Genexus™ Dx GX5™ Chip and Genexus™ Coupler</tradeName>
    <deviceName>Ion Torrent™ Genexus™ Dx GX5™ Chip and Genexus™ Coupler, a part of Ion Genexus™ Dx Reagents and Consumables</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50425 (A54106)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:11.459Z</lastUpdated>
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  <row>
    <udiDi>10190302017497</udiDi>
    <basicUdiDi>0190302A50431RA</basicUdiDi>
    <tradeName>Genexus™ Dx Strip 4</tradeName>
    <deviceName>Ion Torrent™ Genexus™ Dx Templating Strips 3-GX5™ and 4, a part of Ion Genexus™ Dx Reagents and Consumables</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50863 (A50431)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:10.660Z</lastUpdated>
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  <row>
    <udiDi>10190302017473</udiDi>
    <basicUdiDi>0190302A50430R8</basicUdiDi>
    <tradeName>Genexus™ Dx Strip 2-HD</tradeName>
    <deviceName>Ion Torrent™ Genexus™ Dx Library Strips 1 and 2-HD, a part of Ion Genexus™ Dx Reagents and Consumables</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50861 (A50430, A50430RR)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:09.856Z</lastUpdated>
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    <udiDi>10190302006002</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Dynamag™ 16-2mL Tube Dx</tradeName>
    <deviceName>Ion PGM Dx™ Consumables</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A31346 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:50.656Z</lastUpdated>
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