<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-APOA2601EL</udiDi>
    <basicUdiDi>B-APOA2601EL</basicUdiDi>
    <tradeName>Apolipoprotein A2 Reagent Kit</tradeName>
    <deviceName>Apolipoprotein A2 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>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APOA26011Y, APOA26012Y, APOA26013Y, APOA26014Y, APOA26015Y, APOA26011N, APOA26012N, APOA26013N, APOA26014N, APOA26015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:36:10.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020023</udiDi>
    <basicUdiDi>B-00816426020023</basicUdiDi>
    <tradeName>K-ASSAY Apo AII</tradeName>
    <deviceName>Apo AII Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:18.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752144</udiDi>
    <basicUdiDi>B-06936595752144</basicUdiDi>
    <tradeName>Apolipoprotein C2 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>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ488Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:19.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752137</udiDi>
    <basicUdiDi>B-06936595752137</basicUdiDi>
    <tradeName>Apolipoprotein A2 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>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ487Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:18.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768007217</udiDi>
    <basicUdiDi>0405686900954W7</basicUdiDi>
    <tradeName>N Antiserum to Human Apolipoprotein A-II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:49:42.824Z</lastUpdated>
  </row>
</eudamedExport>