<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-A24295U8</udiDi>
    <basicUdiDi>B-A24295U8</basicUdiDi>
    <tradeName>Access HBs Ag Confirmatory</tradeName>
    <deviceName>Access HBs Ag Confirmatory</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>W0105020202</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A24295</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:45.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34240FZ</udiDi>
    <basicUdiDi>B-34240FZ</basicUdiDi>
    <tradeName>Access HBc Ab</tradeName>
    <deviceName>Access HBc Ab</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>W0105020202</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:35.164Z</lastUpdated>
  </row>
</eudamedExport>