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<eudamedExport entity="devices">
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    <udiDi>04987666528559</udiDi>
    <basicUdiDi>150995901ZM062100GD</basicUdiDi>
    <tradeName>MICROPLATE TYPE P4 (12PCS/SET)</tradeName>
    <deviceName>MICROPLATE TYPE P4 (12PCS/SET)</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></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZM062100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:42:20.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987666527439</udiDi>
    <basicUdiDi>150995901ZM047000GM</basicUdiDi>
    <tradeName>MICROPLATE TYPE P3 (12PCS/SET)</tradeName>
    <deviceName>MICROPLATE TYPE P3 (12PCS/SET)</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></emdnCode>
    <emdnDescription>BLOOD GROUPING ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZM047000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:42:19.970Z</lastUpdated>
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  <row>
    <udiDi>04987666524582</udiDi>
    <basicUdiDi>150995901ZM006300FH</basicUdiDi>
    <tradeName>Sample Cup, Plastic (pkg. of 100)</tradeName>
    <deviceName>Sample Cup, Plastic (pkg. of 100)</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></emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZM006300</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:42:19.163Z</lastUpdated>
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  <row>
    <udiDi>04987666524575</udiDi>
    <basicUdiDi>150995901ZM006200FC</basicUdiDi>
    <tradeName>Sample Cup, Glass (pkg. of 100)</tradeName>
    <deviceName>Sample Cup, Glass (pkg. of 100)</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></emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZM006200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:42:18.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590797386</udiDi>
    <basicUdiDi>150995901D15499RS</basicUdiDi>
    <tradeName>Access p-Tau217 QC</tradeName>
    <deviceName>Access p-Tau217 QC</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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15499</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:29.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590797379</udiDi>
    <basicUdiDi>150995901D14563R3</basicUdiDi>
    <tradeName>Access p-Tau217 Calibrators</tradeName>
    <deviceName>Access p-Tau217 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>W0102152208</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D14563</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:28.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590794507</udiDi>
    <basicUdiDi>150995901D14170QC</basicUdiDi>
    <tradeName>Access p-Tau217</tradeName>
    <deviceName>Access p-Tau217</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>W0102019017</emdnCode>
    <emdnDescription>PHOSPHORYLATED TAU (PTAU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D14170</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:27.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590787127</udiDi>
    <basicUdiDi>150995901AccMeMedBVQCZ4</basicUdiDi>
    <tradeName>Access MeMed BV QC (Kit)</tradeName>
    <deviceName>Access MeMed BV QC (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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D05593</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:26.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590787110</udiDi>
    <basicUdiDi>150995901AccMeMedBVCalLB</basicUdiDi>
    <tradeName>Access MeMed BV Calibrator (Kit)</tradeName>
    <deviceName>Access MeMed BV Calibrator (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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D05592</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:23.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590787103</udiDi>
    <basicUdiDi>150995901AccMeMedBVFH</basicUdiDi>
    <tradeName>Access MeMed BV Reagent Kit</tradeName>
    <deviceName>Access MeMed BV Reagent 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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D05581</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:22.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590786533</udiDi>
    <basicUdiDi>150995901BNPIIBE</basicUdiDi>
    <tradeName>Access BNP II</tradeName>
    <deviceName>Access BNP 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D06227</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:21.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590780982</udiDi>
    <basicUdiDi>150995901AccFT4BXR</basicUdiDi>
    <tradeName>Access Free T4</tradeName>
    <deviceName>Access Free T4</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>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C76421</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:19.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590763527</udiDi>
    <basicUdiDi>150995901AccTGAbBJT</basicUdiDi>
    <tradeName>Access Thyroglobulin Antibody II Reagent Pack</tradeName>
    <deviceName>Access Thyroglobulin Antibody II 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>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86552</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:17.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590754501</udiDi>
    <basicUdiDi>150995901AccTgBRM</basicUdiDi>
    <tradeName>Access Thyroglobulin Reagent Pack</tradeName>
    <deviceName>Access Thyroglobulin 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>W01020408</emdnCode>
    <emdnDescription>THYROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C71762</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:15.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590754495</udiDi>
    <basicUdiDi>150995901AccTT4IICalZ3</basicUdiDi>
    <tradeName>Access Total T4 II Calibrators</tradeName>
    <deviceName>Access Total T4 II 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>C69048</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:15.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590754488</udiDi>
    <basicUdiDi>150995901AccTT4IIJC</basicUdiDi>
    <tradeName>Access Total T4 II Reagent Pack</tradeName>
    <deviceName>Access Total T4 II 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>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C69047</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:13.523Z</lastUpdated>
  </row>
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    <udiDi>15099590752705</udiDi>
    <basicUdiDi>150995901C81798TB</basicUdiDi>
    <tradeName>Access Progesterone II Sample Diluent</tradeName>
    <deviceName>Access Progesterone II Sample Diluent</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>C81798</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:11.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590752699</udiDi>
    <basicUdiDi>150995901C78021SB</basicUdiDi>
    <tradeName>Access Progesterone II Calibrators</tradeName>
    <deviceName>Access Progesterone II 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>C78021</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:09.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590752682</udiDi>
    <basicUdiDi>150995901C7802XM</basicUdiDi>
    <tradeName>Access Progesterone II</tradeName>
    <deviceName>Access Progesterone 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C78020</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:08.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590750961</udiDi>
    <basicUdiDi>150995901AccBNPCal4R</basicUdiDi>
    <tradeName>Access BNP Calibrators</tradeName>
    <deviceName>Access BNP 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>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>98202</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:07.111Z</lastUpdated>
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</eudamedExport>