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<eudamedExport entity="devices">
  <row>
    <udiDi>15099590817404</udiDi>
    <basicUdiDi>150995909AccEPOCalDP</basicUdiDi>
    <tradeName>Access EPO Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16365</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:45:09.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590816735</udiDi>
    <basicUdiDi>150995909AccuE3WN</basicUdiDi>
    <tradeName>Access Unconjugated Estriol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33570</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:45:08.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590816742</udiDi>
    <basicUdiDi>150995909AccuE3CalMG</basicUdiDi>
    <tradeName>Access Unconjugated Estriol Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33575</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:45:08.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817855</udiDi>
    <basicUdiDi>150995909AccEstriolCW</basicUdiDi>
    <tradeName>Access Unconjugated Estriol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C22255</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:44:54.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817862</udiDi>
    <basicUdiDi>150995909AccEstriolCalGN</basicUdiDi>
    <tradeName>Access Unconjugated Estriol Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C22256</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:44:54.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590816773</udiDi>
    <basicUdiDi>150995909AccCortFF</basicUdiDi>
    <tradeName>Access Cortisol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:44:53.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590816780</udiDi>
    <basicUdiDi>150995909AccCortCal3H</basicUdiDi>
    <tradeName>Access Cortisol Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33605</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:44:40.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590816797</udiDi>
    <basicUdiDi>150995909AccCortCalS0X3</basicUdiDi>
    <tradeName>Access Cortisol S0 Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33606</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:44:40.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817503</udiDi>
    <basicUdiDi>150995909AccsTfRJG</basicUdiDi>
    <tradeName>Access sTFR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A32493</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:44:38.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817510</udiDi>
    <basicUdiDi>150995909AccsTfRCal6X</basicUdiDi>
    <tradeName>Access sTFR Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A32494</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:44:38.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817749</udiDi>
    <basicUdiDi>150995909AccsTfRQC13G</basicUdiDi>
    <tradeName>Access sTfR QC1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B11056</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:43:57.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817756</udiDi>
    <basicUdiDi>150995909AccsTfRQC239M</basicUdiDi>
    <tradeName>Access sTfR QC2 and QC3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B11057</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:43:57.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590816827</udiDi>
    <basicUdiDi>150995909AccTT3TP</basicUdiDi>
    <tradeName>Access Total T3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33830</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:33:26.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590816834</udiDi>
    <basicUdiDi>150995909AccTT3CalF9</basicUdiDi>
    <tradeName>Access Total T3 Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33835</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:33:26.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817350</udiDi>
    <basicUdiDi>150995909AccTPOAbTS</basicUdiDi>
    <tradeName>Access TPO Antibody</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A12985</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:33:25.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817480</udiDi>
    <basicUdiDi>150995909AccTPOAbCalLG</basicUdiDi>
    <tradeName>Access TPO Antibody Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18227</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:33:15.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817527</udiDi>
    <basicUdiDi>150995909AccTGAb8F</basicUdiDi>
    <tradeName>Access Thyroglobulin Antibody II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A32898</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:33:15.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590817565</udiDi>
    <basicUdiDi>150995909AccTGAbCalB6</basicUdiDi>
    <tradeName>Access Thyroglobulin Antibody II Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A36920</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:33:14.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590818357</udiDi>
    <basicUdiDi>150995909AccTGAbBQK</basicUdiDi>
    <tradeName>Access Thyroglobulin Antibody II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86552</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:33:14.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590816599</udiDi>
    <basicUdiDi>150995909AcchLHWJ</basicUdiDi>
    <tradeName>Access hLH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051071</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:33:13.942Z</lastUpdated>
  </row>
</eudamedExport>