<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00842768007286</udiDi>
    <basicUdiDi>0405686900955W9</basicUdiDi>
    <tradeName>N Apolipoprotein E</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT_N_Apo_E</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:37.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOE601WG</udiDi>
    <basicUdiDi>B-APOE601WG</basicUdiDi>
    <tradeName>Apolipoprotein E Reagent Kit</tradeName>
    <deviceName>Apolipoprotein E Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOE6011Y, APOE6012Y, APOE6013Y, APOE6014Y, APOE6015Y, APOE6011N, APOE6012N, APOE6013N, APOE6014N, APOE6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:36:16.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1937A</udiDi>
    <basicUdiDi>B-1937A</basicUdiDi>
    <tradeName>D-1937A</tradeName>
    <deviceName>Apolipoprotein E Test Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:16:31.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129742</udiDi>
    <basicUdiDi>B-06974760129742</basicUdiDi>
    <tradeName>06974760129742</tradeName>
    <deviceName>Apolipoprotein E （ApoE）Assay Kit （Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×45 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:31.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674868255</udiDi>
    <basicUdiDi>B-06971674868255</basicUdiDi>
    <tradeName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>质控品：1mL×1（92012）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:38:40.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674867920</udiDi>
    <basicUdiDi>B-06971674867920</basicUdiDi>
    <tradeName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>校准品：1mL×1（91023）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:37:24.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674866688</udiDi>
    <basicUdiDi>B-06971674866688</basicUdiDi>
    <tradeName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×1  R2:6mL×1（702）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:31:57.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674866671</udiDi>
    <basicUdiDi>B-06971674866671</basicUdiDi>
    <tradeName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×4  R2:6mL×4（709）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:31:55.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674866664</udiDi>
    <basicUdiDi>B-06971674866664</basicUdiDi>
    <tradeName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×2  R2:20mL×2（701）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:31:54.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967204657</udiDi>
    <basicUdiDi>B-06941967204657</basicUdiDi>
    <tradeName>06941967204657</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.02.08.EC.01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:47:11.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750492</udiDi>
    <basicUdiDi>B-06936595750492</basicUdiDi>
    <tradeName>Apolipoprotein E Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ428Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:35.402Z</lastUpdated>
  </row>
</eudamedExport>