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    <udiDi>06975061571612</udiDi>
    <basicUdiDi>697506157OPqPCR1600BL</basicUdiDi>
    <tradeName>Real-time Fluorescence Quantitative PCR lnstrument</tradeName>
    <deviceName>Real-time fluorecence quantitatine PCR instrument</deviceName>
    <manufacturerName>Wuxi Opulen Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023008</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:59:41.898Z</lastUpdated>
  </row>
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    <udiDi>06975061571605</udiDi>
    <basicUdiDi>697506157OPqPCR1600C65</basicUdiDi>
    <tradeName>Real time fluorescence quantitative PCR  Device</tradeName>
    <deviceName>Real time fluorescence quantitative PCR Device</deviceName>
    <manufacturerName>Wuxi Opulen Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023008</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1722023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:59:40.270Z</lastUpdated>
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    <udiDi>06975061570028</udiDi>
    <basicUdiDi>697506157L04009H</basicUdiDi>
    <tradeName>HyperLyse</tradeName>
    <deviceName>HyperLyse</deviceName>
    <manufacturerName>Wuxi Opulen Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023008</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</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>1722028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:59:37.892Z</lastUpdated>
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