<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-A40706U2</udiDi>
    <basicUdiDi>B-A40706U2</basicUdiDi>
    <tradeName>Access CMV IgM, Calibrators</tradeName>
    <deviceName>Access CMV IgM, Calibrators</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 B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A40706</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:24.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A40703TU</udiDi>
    <basicUdiDi>B-A40703TU</basicUdiDi>
    <tradeName>Access CMV IgG Calibrators</tradeName>
    <deviceName>Access CMV IgG Calibrators</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 B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A40703</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:21.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A31589UJ</udiDi>
    <basicUdiDi>B-A31589UJ</basicUdiDi>
    <tradeName>Access Toxo IgG Calibrators</tradeName>
    <deviceName>Access Toxo IgG Calibrators</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 B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A31589</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:09.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34445GM</udiDi>
    <basicUdiDi>B-34445GM</basicUdiDi>
    <tradeName>Access RUBELLA IgM CALIBRATORS</tradeName>
    <deviceName>Access RUBELLA IgM CALIBRATORS</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 B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34445</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:28:03.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577177049</udiDi>
    <basicUdiDi>697015090000276HT</basicUdiDi>
    <tradeName>AutoLumo B19 IgM Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA170201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:16:17.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577177018</udiDi>
    <basicUdiDi>697015090000275HR</basicUdiDi>
    <tradeName>AutoLumo B19 IgG Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA170101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:16:16.568Z</lastUpdated>
  </row>
</eudamedExport>