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<eudamedExport entity="devices">
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    <udiDi>15099590542443</udiDi>
    <basicUdiDi>150995901LSPREPREAGENT35</basicUdiDi>
    <tradeName>IMMUNOPREP Reagent System</tradeName>
    <deviceName>IMMUNOPREP REAGENT WHOLE BLOOD LYSING</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>7546999</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:35.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590540272</udiDi>
    <basicUdiDi>150995901LSMABEA</basicUdiDi>
    <tradeName>CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent</tradeName>
    <deviceName>CYTO-STAT tetraCHROME</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>W0103080106</emdnCode>
    <emdnDescription>ANTIBODIES FOR LYMPHOCYTE SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607073</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:34.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590540210</udiDi>
    <basicUdiDi>150995901LSIMMUNOTROLXV</basicUdiDi>
    <tradeName>IMMUNO-TROL Low 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080403</emdnCode>
    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607098</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:30.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590232412</udiDi>
    <basicUdiDi>150995901AccCKMBCalS5</basicUdiDi>
    <tradeName>Access CK-MB Calibrators</tradeName>
    <deviceName>Access CK-MB 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>386372</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:09.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590232382</udiDi>
    <basicUdiDi>150995901AccOVMonRW</basicUdiDi>
    <tradeName>Access OV Monitor (Reagent Pack)</tradeName>
    <deviceName>Access OV Monitor (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>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>386357</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:05.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590232375</udiDi>
    <basicUdiDi>150995901AccOVMonCalTC</basicUdiDi>
    <tradeName>Access OV Monitor (Calibrators)</tradeName>
    <deviceName>Access OV Monitor (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>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>386358</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:04.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590232337</udiDi>
    <basicUdiDi>150995901AccHfPSACalDL</basicUdiDi>
    <tradeName>Access Hybritech free PSA (Calibrators)</tradeName>
    <deviceName>Access Hybritech free PSA (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>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:56.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590232306</udiDi>
    <basicUdiDi>150995901AccOstCalTT</basicUdiDi>
    <tradeName>Access Ostase Calibrators</tradeName>
    <deviceName>Access Ostase 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37305</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:39.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590232276</udiDi>
    <basicUdiDi>150995901AcchLHCalFQ</basicUdiDi>
    <tradeName>Access hLH Calibrators</tradeName>
    <deviceName>Access hLH 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33515</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:38.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590232269</udiDi>
    <basicUdiDi>150995901AccProlCalYZ</basicUdiDi>
    <tradeName>Access Prolactin (Calibrators)</tradeName>
    <deviceName>Access Prolactin (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>33535</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:37.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231866</udiDi>
    <basicUdiDi>150995901AccBRMonCalHH</basicUdiDi>
    <tradeName>Access BR Monitor (Calibrators)</tradeName>
    <deviceName>Access BR Monitor (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>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>387647</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:33.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231859</udiDi>
    <basicUdiDi>150995901AccBRMonLK</basicUdiDi>
    <tradeName>Access BR Monitor (Reagent Pack)</tradeName>
    <deviceName>Access BR Monitor (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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>387620</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:32.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231842</udiDi>
    <basicUdiDi>150995901AccGIMonLB</basicUdiDi>
    <tradeName>Access GI Monitor (Reagent Pack)</tradeName>
    <deviceName>Access GI Monitor (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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>387687</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:31.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231835</udiDi>
    <basicUdiDi>150995901AccGIMonCalFP</basicUdiDi>
    <tradeName>Access GI Monitor (Calibrators)</tradeName>
    <deviceName>Access GI Monitor (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>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>387688</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:30.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231699</udiDi>
    <basicUdiDi>150995901AccMyoCalTY</basicUdiDi>
    <tradeName>Access Myoglobin Calibrators</tradeName>
    <deviceName>Access Myoglobin 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>973244</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:26.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231484</udiDi>
    <basicUdiDi>150995901AccAFPCalZH</basicUdiDi>
    <tradeName>Access AFP (Calibrators)</tradeName>
    <deviceName>Access AFP (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>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:20.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231392</udiDi>
    <basicUdiDi>150995901AccE2CalBT</basicUdiDi>
    <tradeName>Access Estradiol Calibrators</tradeName>
    <deviceName>Access Estradiol 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33545</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:18.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231385</udiDi>
    <basicUdiDi>150995901AccE2S0CalFS</basicUdiDi>
    <tradeName>Access Estradiol Calibrator S0</tradeName>
    <deviceName>Access Estradiol Calibrator S0</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33546</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:14.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231361</udiDi>
    <basicUdiDi>150995901AccProgCalXW</basicUdiDi>
    <tradeName>Access Progesterone Calibrators</tradeName>
    <deviceName>Access Progesterone 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33555</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:12.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231354</udiDi>
    <basicUdiDi>150995901AccProgCalS0R3</basicUdiDi>
    <tradeName>Access Progesterone Calibrator S0</tradeName>
    <deviceName>Access Progesterone Calibrator S0</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33556</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:11.615Z</lastUpdated>
  </row>
</eudamedExport>