<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-660709827</udiDi>
    <basicUdiDi>B-660709827</basicUdiDi>
    <tradeName>IMMUNO-TROL Low Cells</tradeName>
    <deviceName>IMMUNO-TROL Low Cells</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>6607098</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:32.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6607077ZU</udiDi>
    <basicUdiDi>B-6607077ZU</basicUdiDi>
    <tradeName>IMMUNO-TROL Cells</tradeName>
    <deviceName>IMMUNO-TROL Cells</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>6607077</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:27.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6607054ZG</udiDi>
    <basicUdiDi>B-6607054ZG</basicUdiDi>
    <tradeName>MsIgG1-FITC/MslgG1-RD1/MslgG1-PC5</tradeName>
    <deviceName>MsIgG1-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>6607054</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:46:19.822Z</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-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-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-6604112YG</udiDi>
    <basicUdiDi>B-6604112YG</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MsIgG1-RD1</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MsIgG1-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>6604112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:29.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-66038772B</udiDi>
    <basicUdiDi>B-66038772B</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MsIgM-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MsIgM-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>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603877</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:18.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-660386422</udiDi>
    <basicUdiDi>B-660386422</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MslgG1-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MslgG1-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>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603864</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:18.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603855ZW</udiDi>
    <basicUdiDi>B-6603855ZW</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MsIgG2a-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MsIgG2a-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>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603855</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:04.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603853ZS</udiDi>
    <basicUdiDi>B-6603853ZS</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MslgG2b-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MslgG2b-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>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603853</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:45:03.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-660379528</udiDi>
    <basicUdiDi>B-660379528</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG2a-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG2a-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>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603795</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:48.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-66037962A</udiDi>
    <basicUdiDi>B-66037962A</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG1-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG1-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>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603796</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:46.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603473ZC</udiDi>
    <basicUdiDi>B-6603473ZC</basicUdiDi>
    <tradeName>IMMUNO-BRITE Standards Kit</tradeName>
    <deviceName>IMMUNO-BRITE Standards 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>W0103080401</emdnCode>
    <emdnDescription>SETUP BEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603473</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:30.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603262YV</udiDi>
    <basicUdiDi>B-6603262YV</basicUdiDi>
    <tradeName>COULTER CLONE MY4-RD1</tradeName>
    <deviceName>COULTER CLONE MY4-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>6602884</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:27.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6602928ZR</udiDi>
    <basicUdiDi>B-6602928ZR</basicUdiDi>
    <tradeName>COULTER Clone MsIgG1-FITC</tradeName>
    <deviceName>COULTER Clone MsIgG1-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>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6602928</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:22.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382903403356</udiDi>
    <basicUdiDi>038290PCKPHAXE9K</basicUdiDi>
    <tradeName>BD TRUCOUNT</tradeName>
    <deviceName>Trucount counting tubes &amp; control beads</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340335</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:28.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PartNumber17562129</udiDi>
    <basicUdiDi>B-PartNumber17562129</basicUdiDi>
    <tradeName>LeukoSure Enumeration Kit</tradeName>
    <deviceName>LeukoSure Enumeration 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>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175621</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:12:18.237Z</lastUpdated>
  </row>
</eudamedExport>