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    <basicUdiDi>69557927S3056E000001S7</basicUdiDi>
    <tradeName>06955792700895</tradeName>
    <deviceName>Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3056E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:20:01.735Z</lastUpdated>
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    <udiDi>06950917910555</udiDi>
    <basicUdiDi>B-06950917910555</basicUdiDi>
    <tradeName>06950917910555</tradeName>
    <deviceName>Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Triplex International Biosciences (China) Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001097</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C011936</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:26:54.023Z</lastUpdated>
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