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<eudamedExport entity="devices">
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    <udiDi>15099590750954</udiDi>
    <basicUdiDi>150995901AccBNPQCFF</basicUdiDi>
    <tradeName>Access BNP QC</tradeName>
    <deviceName>Access BNP QC</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>98201</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:04.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590750947</udiDi>
    <basicUdiDi>150995901AccBNPMT</basicUdiDi>
    <tradeName>Access BNP (Reagent Pack)</tradeName>
    <deviceName>Access BNP (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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>98200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:03.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590750312</udiDi>
    <basicUdiDi>150995901CellMekH8</basicUdiDi>
    <tradeName>15099590750312</tradeName>
    <deviceName>CellMek SPS</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069001</emdnCode>
    <emdnDescription>AUTOSAMPLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C44603</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:02.308Z</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>15099590745141</udiDi>
    <basicUdiDi>150995901C39449SG</basicUdiDi>
    <tradeName>Access anti-HAV IgM QC</tradeName>
    <deviceName>Access anti-HAV IgM QC</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>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39449</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:58.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590745110</udiDi>
    <basicUdiDi>150995901C39446SA</basicUdiDi>
    <tradeName>Access anti-HAV QC</tradeName>
    <deviceName>Access anti-HAV QC</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>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39446</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:56.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590745127</udiDi>
    <basicUdiDi>150995901C39447SC</basicUdiDi>
    <tradeName>Access anti-HAV IgM</tradeName>
    <deviceName>C39447</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>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39447</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:55.896Z</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>
  <row>
    <udiDi>15099590745097</udiDi>
    <basicUdiDi>150995901C39444S6</basicUdiDi>
    <tradeName>Access anti-HAV</tradeName>
    <deviceName>Access anti-HAV</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>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39444</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:39.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590744380</udiDi>
    <basicUdiDi>150995901A9000TBhCGLA</basicUdiDi>
    <tradeName>Access Total βhCG (Reagent Pack)</tradeName>
    <deviceName>Access Total βhCG (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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C28645</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:38.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590744359</udiDi>
    <basicUdiDi>150995901LumiphosVQ</basicUdiDi>
    <tradeName>Lumi-Phos PRO</tradeName>
    <deviceName>Lumi-Phos PRO</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B96000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:35.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590742461</udiDi>
    <basicUdiDi>150995901ALLEGRAV15RQ9</basicUdiDi>
    <tradeName>Allegra V-15R</tradeName>
    <deviceName>Allegra V-15R Centrifuge</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069003</emdnCode>
    <emdnDescription>CENTRIFUGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C63125</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:34.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590733377</udiDi>
    <basicUdiDi>150995901AccCPep56</basicUdiDi>
    <tradeName>Access C-Peptide (Reagent Pack)</tradeName>
    <deviceName>Access C-Peptide (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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C33451</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:33.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590733360</udiDi>
    <basicUdiDi>150995901AccCPepCalBR</basicUdiDi>
    <tradeName>Access C-Peptide (Calibrators)</tradeName>
    <deviceName>Access C-Peptide (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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C31860</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:31.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590732103</udiDi>
    <basicUdiDi>150995901DXI9000INSTRTQ</basicUdiDi>
    <tradeName>DxI 9000 Access Immunoassay Analyzer</tradeName>
    <deviceName>DxI 9000 Access Immunoassay Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020103</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput &gt; 250 and &lt;= 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C11137</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:29.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590730031</udiDi>
    <basicUdiDi>150995901C39283S6</basicUdiDi>
    <tradeName>DxFlex Daily QC Fluorospheres</tradeName>
    <deviceName>DxFLEX Daily QC Fluorospheres</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080699</emdnCode>
    <emdnDescription>REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39283</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:27.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590711931</udiDi>
    <basicUdiDi>150995901AVANTIJXNM3</basicUdiDi>
    <tradeName>Avanti JXN-26, 230V, 50HZ, 24A - IVD centrifuge</tradeName>
    <deviceName>Avanti JXN-26, Avanti JXN-30</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069003</emdnCode>
    <emdnDescription>CENTRIFUGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B38623</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:27.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590711795</udiDi>
    <basicUdiDi>150995901MICROFUGE2064</basicUdiDi>
    <tradeName>Microfuge 20R 220V-240V, 50/60 Hz, IVD</tradeName>
    <deviceName>Microfuge 20, Microfuge 20R</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069003</emdnCode>
    <emdnDescription>CENTRIFUGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B31611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:25.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590705084</udiDi>
    <basicUdiDi>150995901FCANSYSSWJ2</basicUdiDi>
    <tradeName>Kaluza C Perpetual License</tradeName>
    <deviceName>Kaluza C Software</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040182</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C10574</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:23.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590702137</udiDi>
    <basicUdiDi>150995901AccEstriolCal5W</basicUdiDi>
    <tradeName>Access Unconjugated Estriol (Calibrators)</tradeName>
    <deviceName>Access Unconjugated Estriol (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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C22256</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:21.414Z</lastUpdated>
  </row>
</eudamedExport>