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    <tradeName>Sample Preservation Buffer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xukang Medical Technology (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017865</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XK-043-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:09:35.493Z</lastUpdated>
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    <udiDi>06974679040329</udiDi>
    <basicUdiDi>697467904XKUDI00119V</basicUdiDi>
    <tradeName>NGS Universal Dual Index Kit (MGI)</tradeName>
    <deviceName>-</deviceName>
    <manufacturerName>Xukang Medical Technology (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017865</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EK008-001-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:09:34.684Z</lastUpdated>
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    <udiDi>06974679040305</udiDi>
    <basicUdiDi>697467904XKUDI00109T</basicUdiDi>
    <tradeName>Pre-amplification Buffer Kit (MGI)</tradeName>
    <deviceName>-</deviceName>
    <manufacturerName>Xukang Medical Technology (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017865</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:09:33.081Z</lastUpdated>
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    <udiDi>06974679040114</udiDi>
    <basicUdiDi>697467904XKUDI0008A8</basicUdiDi>
    <tradeName>Universal Library Preparation Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xukang Medical Technology (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017865</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XK-011-48-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:09:30.677Z</lastUpdated>
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    <udiDi>06974318132910</udiDi>
    <basicUdiDi>697431813OS-KitS2</basicUdiDi>
    <tradeName>Universal DNBSEQ OneStep DNB Make Reagent Kit OS-App</tradeName>
    <deviceName>Universal DNBSEQ OneStep DNB Make Reagent Kit</deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002480-00</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:51:57.821Z</lastUpdated>
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    <udiDi>06974318130589</udiDi>
    <basicUdiDi>697431813C-KitGE</basicUdiDi>
    <tradeName>Universal Cyclization Reaction Kit SD-SB</tradeName>
    <deviceName>Universal Cyclization Reaction Kit</deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-000141-00</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:51:50.610Z</lastUpdated>
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    <udiDi>06974318130039</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit G50 SM FCL SE50</tradeName>
    <deviceName>Universal Sequencing Reaction Kit</deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000022469</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:51:21.748Z</lastUpdated>
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    <udiDi>06973315739351</udiDi>
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    <tradeName>Vazyme Target Capture Hybridization and Wash Pro Kit</tradeName>
    <deviceName>Vazyme Target Capture Hybridization and Wash Pro Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC401ME-C1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:29:26.944Z</lastUpdated>
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    <udiDi>06973315739344</udiDi>
    <basicUdiDi>6973315739344B2</basicUdiDi>
    <tradeName>Vazyme Target Capture Hybridization and Wash Kit</tradeName>
    <deviceName>Vazyme Target Capture Hybridization and Wash Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC403ME-C1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:29:26.138Z</lastUpdated>
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    <udiDi>06973315739337</udiDi>
    <basicUdiDi>6973315739337B5</basicUdiDi>
    <tradeName>Vazyme MedExome Dx Panel</tradeName>
    <deviceName>Vazyme MedExome Dx Panel</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC004ME-C1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:29:25.330Z</lastUpdated>
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    <udiDi>06973315739290</udiDi>
    <basicUdiDi>6973315739290B4</basicUdiDi>
    <tradeName>Vazyme Comprehensive Exome Dx Panel</tradeName>
    <deviceName>Vazyme Comprehensive Exome Dx Panel</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC001ME-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:29:24.547Z</lastUpdated>
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    <udiDi>06973315738996</udiDi>
    <basicUdiDi>6973315738996CC</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for MGI</tradeName>
    <deviceName>VAHTS DNA Library Prep Kit for MGI</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDM609ME-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:29:20.524Z</lastUpdated>
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    <udiDi>06973315736343</udiDi>
    <basicUdiDi>6973315736343AB</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for Illumina</tradeName>
    <deviceName>VAHTS DNA Library Prep Kit for Illumina</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ND609ME-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:29:11.734Z</lastUpdated>
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    <udiDi>06973315736008</udiDi>
    <basicUdiDi>69733157360089S</basicUdiDi>
    <tradeName>Equalbit 1 × dsDNA HS Assay Kit</tradeName>
    <deviceName>Equalbit 1 × dsDNA HS Assay Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EQ121ME-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:29:07.738Z</lastUpdated>
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    <udiDi>06972129852348</udiDi>
    <basicUdiDi>697212985NAERN8</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Reagents (Magnetic Bead)</tradeName>
    <deviceName>Nucleic Acid Extraction Reagents (Magnetic Bead)</deviceName>
    <manufacturerName>Hunan Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029972</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LTN010101</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:34:30.607Z</lastUpdated>
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    <udiDi>06971980730185</udiDi>
    <basicUdiDi>697198037018MT</basicUdiDi>
    <tradeName>06971980730185</tradeName>
    <deviceName>Nucleic Acid Extraction and Purification Kit</deviceName>
    <manufacturerName>Hangzhou New Horizon Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027517</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:24:37.162Z</lastUpdated>
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    <udiDi>06971980730116</udiDi>
    <basicUdiDi>697198037011MD</basicUdiDi>
    <tradeName>06971980730116</tradeName>
    <deviceName>Nucleic Acid Extraction/Purification Reagent</deviceName>
    <manufacturerName>Hangzhou New Horizon Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027517</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:24:34.761Z</lastUpdated>
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    <udiDi>06438147393701</udiDi>
    <basicUdiDi>6438147Vanadis_Buffer2VW</basicUdiDi>
    <tradeName>Vanadis Core Buffer kit v2</tradeName>
    <deviceName>Vanadis Core Buffer kit v2</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3223-0020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:20.688Z</lastUpdated>
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    <basicUdiDi>6438147Eonis_ExtractW3</basicUdiDi>
    <tradeName>Eonis DNA Extraction kit</tradeName>
    <deviceName>Eonis DNA Extraction kit</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3240-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:16.687Z</lastUpdated>
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    <udiDi>06438147370511</udiDi>
    <basicUdiDi>6438147Vanadis_VPRH</basicUdiDi>
    <tradeName>Vanadis View Plate</tradeName>
    <deviceName>Vanadis View Plate</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3224-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:13.479Z</lastUpdated>
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