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    <tradeName>06975196540088</tradeName>
    <deviceName>Isothermal Nucleic Acid Amplification Detector</deviceName>
    <manufacturerName>Wuxi Qitian Biological Science Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023012</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>829</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:24:18.199Z</lastUpdated>
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    <udiDi>06975196540064</udiDi>
    <basicUdiDi>697519654823PY</basicUdiDi>
    <tradeName>06975196540064</tradeName>
    <deviceName>Sample Pretreatment System</deviceName>
    <manufacturerName>Wuxi Qitian Biological Science Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023012</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>823</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:24:14.199Z</lastUpdated>
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    <udiDi>06975196540057</udiDi>
    <basicUdiDi>697519654828QA</basicUdiDi>
    <tradeName>06975196540057</tradeName>
    <deviceName>Isothermal Amplification Fluorescence Detector</deviceName>
    <manufacturerName>Wuxi Qitian Biological Science Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023012</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>828</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:24:13.401Z</lastUpdated>
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