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    <basicUdiDi>081011446R0031CD7</basicUdiDi>
    <tradeName>OnSite® Syphilis Ab Combo Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0031C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T03:42:15.726Z</lastUpdated>
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    <udiDi>00855402007573</udiDi>
    <basicUdiDi>081011446R0192CEF</basicUdiDi>
    <tradeName>OnSite® H. pylori Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0192C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:26.589Z</lastUpdated>
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    <udiDi>00855402007597</udiDi>
    <basicUdiDi>081011446R0186CEN</basicUdiDi>
    <tradeName>OnSite® RSV Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0186C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:26.561Z</lastUpdated>
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    <udiDi>00855402007733</udiDi>
    <basicUdiDi>081011446R0187CER</basicUdiDi>
    <tradeName>OnSite® Influenza A/B Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0187C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:26.534Z</lastUpdated>
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