<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-6607053ZE</udiDi>
    <basicUdiDi>B-6607053ZE</basicUdiDi>
    <tradeName>CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5</tradeName>
    <deviceName>CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5</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>IVDD</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607053</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:18.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6607023Z5</udiDi>
    <basicUdiDi>B-6607023Z5</basicUdiDi>
    <tradeName>CYTO-COMP Cell Kit</tradeName>
    <deviceName>CYTO-COMP Cell Kit</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>IVDD</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607023</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:18.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6607019ZE</udiDi>
    <basicUdiDi>B-6607019ZE</basicUdiDi>
    <tradeName>CYTO-STAT triCHROME CD45-FITC/MslgG1-RD1/MslgG1-PC5</tradeName>
    <deviceName>CYTO-STAT triCHROME CD45-FITC/MslgG1-RD1/MslgG1-PC5</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>IVDD</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607019</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:13.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6607017ZA</udiDi>
    <basicUdiDi>B-6607017ZA</basicUdiDi>
    <tradeName>Cyto-Stat Tirchrome CD45-FITC/CD8-RD1/CD3-PC5</tradeName>
    <deviceName>Cyto-Stat Tirchrome CD45-FITC/CD8-RD1/CD3-PC5</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>IVDD</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607017</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:13.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6607015Z6</udiDi>
    <basicUdiDi>B-6607015Z6</basicUdiDi>
    <tradeName>CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5</tradeName>
    <deviceName>CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5</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>IVDD</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:12.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6607013Z2</udiDi>
    <basicUdiDi>B-6607013Z2</basicUdiDi>
    <tradeName>CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5</tradeName>
    <deviceName>CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5</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>IVDD</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:12.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6607007Z7</udiDi>
    <basicUdiDi>B-6607007Z7</basicUdiDi>
    <tradeName>Flow-Set Fluorospheres</tradeName>
    <deviceName>Flow-Set 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080401</emdnCode>
    <emdnDescription>SETUP BEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607007</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:08.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6605015YQ</udiDi>
    <basicUdiDi>B-6605015YQ</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/84-RD1</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/84-RD1</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>IVDD</legislation>
    <emdnCode>W0103080106</emdnCode>
    <emdnDescription>ANTIBODIES FOR LYMPHOCYTE SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6605015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:06.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604930ZS</udiDi>
    <basicUdiDi>B-6604930ZS</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE CD3 (IgG1)-FITC/T8-RD1</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE CD3 (IgG1)-FITC/T8-RD1</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>IVDD</legislation>
    <emdnCode>W0103080106</emdnCode>
    <emdnDescription>ANTIBODIES FOR LYMPHOCYTE SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604930</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:05.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-66049292C</udiDi>
    <basicUdiDi>B-66049292C</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/T4-RD1</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/T4-RD1</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>IVDD</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604929</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:02.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604627ZN</udiDi>
    <basicUdiDi>B-6604627ZN</basicUdiDi>
    <tradeName>COULTER CLONE CD3 (IgG1)-RD1</tradeName>
    <deviceName>COULTER CLONE CD3 (IgG1)-RD1</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>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604627</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:00.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604625ZJ</udiDi>
    <basicUdiDi>B-6604625ZJ</basicUdiDi>
    <tradeName>COULTER CLONE CD3 (IgG1)-FITC</tradeName>
    <deviceName>COULTER CLONE CD3 (IgG1)-FITC</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>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604625</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:58.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604623ZE</udiDi>
    <basicUdiDi>B-6604623ZE</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC</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>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604623</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:58.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604500YV</udiDi>
    <basicUdiDi>B-6604500YV</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE Mo2-RD1</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE Mo2-RD1</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>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604500</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:52.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604621ZA</udiDi>
    <basicUdiDi>B-6604621ZA</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE CD3 (lgG1)-RD1</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE CD3 (lgG1)-RD1</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>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604621</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:51.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604614ZD</udiDi>
    <basicUdiDi>B-6604614ZD</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE T8-RD1/T4-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE T8-RD1/T4-FITC</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>IVDD</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604614</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:51.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604248ZA</udiDi>
    <basicUdiDi>B-6604248ZA</basicUdiDi>
    <tradeName>COULTER CYTO-TROL Control Cells Kit</tradeName>
    <deviceName>COULTER CYTO-TROL Control Cells Kit</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>IVDD</legislation>
    <emdnCode>W0103080403</emdnCode>
    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604248</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:50.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604119YW</udiDi>
    <basicUdiDi>B-6604119YW</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MsIgG2a-RD1</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MsIgG2a-RD1</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>IVDD</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604119</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:33.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604117YS</udiDi>
    <basicUdiDi>B-6604117YS</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MsIgM-RD1</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MsIgM-RD1</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>IVDD</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604117</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:32.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6604114YL</udiDi>
    <basicUdiDi>B-6604114YL</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE Mo2-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE Mo2-FITC</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>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6604114</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:31.180Z</lastUpdated>
  </row>
</eudamedExport>