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    <basicUdiDi>697477697SRUK01A4</basicUdiDi>
    <tradeName>06974776970307</tradeName>
    <deviceName>Sequencing Reaction Universal Kit (Semiconductor Sequencing)</deviceName>
    <manufacturerName>CapitalBio Genomics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027716</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4C4R/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:27:44.171Z</lastUpdated>
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    <udiDi>06974776970017</udiDi>
    <basicUdiDi>697477697NAEPK019V</basicUdiDi>
    <tradeName>06974776970017</tradeName>
    <deviceName>Nucleic Acid Exctraction/Purification Kit</deviceName>
    <manufacturerName>CapitalBio Genomics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027716</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:27:40.167Z</lastUpdated>
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    <udiDi>06974776970000</udiDi>
    <basicUdiDi>697477697FAL01RS</basicUdiDi>
    <tradeName>06974776970000</tradeName>
    <deviceName>Fetal Aneuploidies (Trisomy 21, Trisomy18 and Trisomy13) Detection Kit</deviceName>
    <manufacturerName>CapitalBio Genomics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027716</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:27:39.380Z</lastUpdated>
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