<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4291315KU</udiDi>
    <basicUdiDi>B-IM4291315KU</basicUdiDi>
    <tradeName>D-IM4291315KU</tradeName>
    <deviceName>HAV IgM Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080902</emdnCode>
    <emdnDescription>HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4291315</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:13:04.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34250G4</udiDi>
    <basicUdiDi>B-34250G4</basicUdiDi>
    <tradeName>Access HBc IgM (Reagent Pack)</tradeName>
    <deviceName>Access HBc IgM (Reagent Pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080902</emdnCode>
    <emdnDescription>HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34250</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:39.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590745134</udiDi>
    <basicUdiDi>150995901C39448SE</basicUdiDi>
    <tradeName>Access anti-HAV IgM Calibrator</tradeName>
    <deviceName>Access anti-HAV IgM Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080902</emdnCode>
    <emdnDescription>HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39448</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:00.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590745103</udiDi>
    <basicUdiDi>150995901C39445S8</basicUdiDi>
    <tradeName>Access anti-HAV Calibrator</tradeName>
    <deviceName>Access anti-HAV Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080902</emdnCode>
    <emdnDescription>HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39445</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:40.636Z</lastUpdated>
  </row>
</eudamedExport>