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<eudamedExport entity="devices">
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    <udiDi>15099590702120</udiDi>
    <basicUdiDi>150995901AccEstriol56</basicUdiDi>
    <tradeName>Access Unconjugated Estriol (Reagent Pack)</tradeName>
    <deviceName>Access Unconjugated Estriol (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>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C22255</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:20.612Z</lastUpdated>
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  <row>
    <udiDi>15099590701727</udiDi>
    <basicUdiDi>150995901C22529QK</basicUdiDi>
    <tradeName>Total Immunoglobulin E (IgE)</tradeName>
    <deviceName>Total Immunoglobulin E (IgE)</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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C22529</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:19.068Z</lastUpdated>
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    <udiDi>15099590701567</udiDi>
    <basicUdiDi>150995901HEMINSTRUMENTRF</basicUdiDi>
    <tradeName>UniCel DxH SMS II Coulter Cellular Analysis</tradeName>
    <deviceName>UniCel DxH SMS II</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>W0202010180</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C11477</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:16.609Z</lastUpdated>
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  <row>
    <udiDi>15099590699406</udiDi>
    <basicUdiDi>150995901AccSE2S0CalMV</basicUdiDi>
    <tradeName>Access Sensitive Estradiol Calibrator S0</tradeName>
    <deviceName>Access Sensitive 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>B97145</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:15.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590699390</udiDi>
    <basicUdiDi>150995901AccSE2Cal28</basicUdiDi>
    <tradeName>Access Sensitive Estradiol Calibrators</tradeName>
    <deviceName>Access Sensitive 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>B84494</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:14.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590699383</udiDi>
    <basicUdiDi>150995901AccSE2MT</basicUdiDi>
    <tradeName>Access Sensitive Estradiol</tradeName>
    <deviceName>Access Sensitive Estradiol</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>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B84493</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:12.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590694913</udiDi>
    <basicUdiDi>150995901AVANTIJ15FZ</basicUdiDi>
    <tradeName>AVANTI J-15R, 200-230 VAC IVD</tradeName>
    <deviceName>Avanti J-15, Avanti J-15R</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>B99515</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:10.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590670825</udiDi>
    <basicUdiDi>150995901LS-1-SheathND</basicUdiDi>
    <tradeName>DxFLEX Sheath Fluid</tradeName>
    <deviceName>DxFLEX Sheath Fluid</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>B73613</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:08.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590663421</udiDi>
    <basicUdiDi>150995901AccVitDDxCalJG</basicUdiDi>
    <tradeName>Access 25(OH) Vitamin D Total Calibrators</tradeName>
    <deviceName>Access 25(OH) Vitamin D Total 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>A98857</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:07.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590663414</udiDi>
    <basicUdiDi>150995901AccVitDA2Cal3F</basicUdiDi>
    <tradeName>Access 25(OH) Vitamin D Total Calibrators</tradeName>
    <deviceName>Access 25(OH) Vitamin D Total 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>B24839</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:06.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590624774</udiDi>
    <basicUdiDi>150995901AccWBII33</basicUdiDi>
    <tradeName>Access Wash Buffer II</tradeName>
    <deviceName>Access Wash Buffer II</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>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16792</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:04.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590616434</udiDi>
    <basicUdiDi>150995901ALLEGRAX30XH</basicUdiDi>
    <tradeName>Allegra X-30, IVD, 100V, 50/60Hz</tradeName>
    <deviceName>Allegra X-30 series 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>B06319</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:02.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590575250</udiDi>
    <basicUdiDi>150995901AcchFSHCalCK</basicUdiDi>
    <tradeName>Access hFSH Calibrators</tradeName>
    <deviceName>Access hFSH 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>33525</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:01.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590575243</udiDi>
    <basicUdiDi>150995901AcchLHSA</basicUdiDi>
    <tradeName>Access hLH Reagent Pack</tradeName>
    <deviceName>Access hLH 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33510</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:00.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590575052</udiDi>
    <basicUdiDi>150995901AccFerRX</basicUdiDi>
    <tradeName>Access Ferritin Reagent Pack</tradeName>
    <deviceName>Access Ferritin 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33020</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:56.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590575045</udiDi>
    <basicUdiDi>150995901AccFerCalJW</basicUdiDi>
    <tradeName>Access Ferritin Calibrators</tradeName>
    <deviceName>Access Ferritin 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>W0102152206</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:55.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590575236</udiDi>
    <basicUdiDi>150995901AcchFSH77</basicUdiDi>
    <tradeName>Access hFSH Reagent Pack</tradeName>
    <deviceName>Access hFSH 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33520</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:54.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590575229</udiDi>
    <basicUdiDi>150995901AccProlD8</basicUdiDi>
    <tradeName>Access Prolactin (Reagent Pack)</tradeName>
    <deviceName>Access Prolactin (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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33530</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:54.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590563547</udiDi>
    <basicUdiDi>150995901LSTQPREPHN</basicUdiDi>
    <tradeName>TQ Prep</tradeName>
    <deviceName>COULTER TQ-Prep Workstation</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>6605429</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:37.325Z</lastUpdated>
  </row>
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    <udiDi>15099590542450</udiDi>
    <basicUdiDi>150995901FLUROSPHRSRP</basicUdiDi>
    <tradeName>Flow-Count Fluorospheres</tradeName>
    <deviceName>Flow-Count 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547053</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:36.525Z</lastUpdated>
  </row>
</eudamedExport>