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    <tradeName>Dry immunoassay analyzer</tradeName>
    <deviceName>Dry immunoassay analyzer</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1FF00003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-11T03:41:20.029Z</lastUpdated>
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    <udiDi>06974576208587</udiDi>
    <basicUdiDi>697457620SSFaciaMP</basicUdiDi>
    <tradeName>Fully automatic chemiluminescence immunoassay analyzer</tradeName>
    <deviceName>Fully automatic chemiluminescence immunoassay analyzer</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2FF00001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:44:56.675Z</lastUpdated>
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    <udiDi>06974576205814</udiDi>
    <basicUdiDi>697457620FGSS01PX</basicUdiDi>
    <tradeName>Substrate Solution</tradeName>
    <deviceName>Substrate Solution</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFQXY04A</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:44:55.882Z</lastUpdated>
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    <udiDi>06974576205777</udiDi>
    <basicUdiDi>697457620FGWS01QT</basicUdiDi>
    <tradeName>Washing Solution</tradeName>
    <deviceName>Washing Solution</deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFQXY02Q</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:44:55.076Z</lastUpdated>
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