<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>14987666542514</udiDi>
    <basicUdiDi>150995901DxC700AU2E</basicUdiDi>
    <tradeName>CHEMISTRY ANALYZER DxC 700 AU for Direct Track Sampling with ISE</tradeName>
    <deviceName></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>W0201010103</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B86446</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T09:58:38.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987666542545</udiDi>
    <basicUdiDi>150995901DxC700AU2E</basicUdiDi>
    <tradeName>CHEMISTRY ANALYZER DxC 700 AU with ISE</tradeName>
    <deviceName></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>W0201010103</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B86444</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T18:23:48.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987666542972</udiDi>
    <basicUdiDi>150995901AU4805D</basicUdiDi>
    <tradeName>Beckman Coulter CHEMISTRY ANALYZER AU480 with ISE</tradeName>
    <deviceName></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>W0201010103</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B96693</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T18:23:48.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987666542996</udiDi>
    <basicUdiDi>150995901AU6805P</basicUdiDi>
    <tradeName>Beckman Coulter CHEMISTRY ANALYZER AU680 for Direct Track Sampling with ISE</tradeName>
    <deviceName></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>W0201010103</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B96695</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T18:23:48.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987666543009</udiDi>
    <basicUdiDi>150995901AU6805P</basicUdiDi>
    <tradeName>Beckman Coulter CHEMISTRY ANALYZER AU680 with ISE</tradeName>
    <deviceName></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>W0201010103</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B96696</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T18:23:48.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987666543023</udiDi>
    <basicUdiDi>150995901AU58003W</basicUdiDi>
    <tradeName>Beckman Coulter CHEMISTRY ANALYZER AU5800, Automation Ready</tradeName>
    <deviceName></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>W0201010107</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B96698</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T18:23:48.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987666545065</udiDi>
    <basicUdiDi>150995901DxC500AUZM</basicUdiDi>
    <tradeName>DxC 500 AU Clinical Chemistry Analyzer</tradeName>
    <deviceName></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>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C63520</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T18:23:48.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-175356PW</udiDi>
    <basicUdiDi>B-175356PW</basicUdiDi>
    <tradeName>COULTER AcT 5diff Autoloader Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175356</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:05.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-175651Q3</udiDi>
    <basicUdiDi>B-175651Q3</basicUdiDi>
    <tradeName>Leuko-Trol Platelet Control Cells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175651</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:04.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-175658QH</udiDi>
    <basicUdiDi>B-175658QH</basicUdiDi>
    <tradeName>Leuko-Trol RBC Control Cells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175658</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:04.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-177017PK</udiDi>
    <basicUdiDi>B-177017PK</basicUdiDi>
    <tradeName>QuickComp 4 Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>177017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:04.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-177018PM</udiDi>
    <basicUdiDi>B-177018PM</basicUdiDi>
    <tradeName>QuickComp 2 Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>177018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:04.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-179310Q2</udiDi>
    <basicUdiDi>B-179310Q2</basicUdiDi>
    <tradeName>COULTER S-CAL Calibrator Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>179310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:04.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33200FE</udiDi>
    <basicUdiDi>B-33200FE</basicUdiDi>
    <tradeName>Access CEA (Reagent Pack)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33205FQ</udiDi>
    <basicUdiDi>B-33205FQ</basicUdiDi>
    <tradeName>Access CEA Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33206FS</udiDi>
    <basicUdiDi>B-33206FS</basicUdiDi>
    <tradeName>Access CEA Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33209FY</udiDi>
    <basicUdiDi>B-33209FY</basicUdiDi>
    <tradeName>Access CEA QC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33209</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33710GA</udiDi>
    <basicUdiDi>B-33710GA</basicUdiDi>
    <tradeName>Access Digoxin (reagent pack)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33710</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33715GL</udiDi>
    <basicUdiDi>B-33715GL</basicUdiDi>
    <tradeName>Access Digoxin Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33715</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33716GN</udiDi>
    <basicUdiDi>B-33716GN</basicUdiDi>
    <tradeName>Access Digoxin Calibrator S0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33716</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.829Z</lastUpdated>
  </row>
</eudamedExport>