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<eudamedExport entity="devices">
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    <udiDi>06973602151316</udiDi>
    <basicUdiDi>697360215GICP5</basicUdiDi>
    <tradeName>Colloidal gold immunochromatography reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIC-S100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602151415</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-M2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602151422</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-M2NT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602151439</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC- NTIMM3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602151613</udiDi>
    <basicUdiDi>697360215GICP5</basicUdiDi>
    <tradeName>Colloidal gold immunochromatography reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIC-M2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.466Z</lastUpdated>
  </row>
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