<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936736067700</udiDi>
    <basicUdiDi>697030147BSBE0001H9</basicUdiDi>
    <tradeName>D-Dimer Assay Kit</tradeName>
    <deviceName>D-Dimer Assay Kit(D-D)  (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Beijing Strong Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000004362</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ETGS8601M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:16:00.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936736052454</udiDi>
    <basicUdiDi>69367360BSBE0002SU</basicUdiDi>
    <tradeName>BSBE</tradeName>
    <deviceName>Potassium Assay Kit(K) (Pyruvate Kinase Method)</deviceName>
    <manufacturerName>Beijing Strong Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000004362</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>POTASSIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETGS4K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:11:02.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970301471018</udiDi>
    <basicUdiDi>B-16970301471018</basicUdiDi>
    <tradeName>16970301471018</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Strong Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000004362</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-02T22:55:36.188Z</lastUpdated>
  </row>
</eudamedExport>