<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00380740138233</udiDi>
    <basicUdiDi>038074LGF0010LB</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i Urine NGAL</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152208</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P2901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T09:01:26.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740121525</udiDi>
    <basicUdiDi>038074AIP0791LM</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i LH</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07P9101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T09:01:20.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740003913</udiDi>
    <basicUdiDi>038074ARP0240NY</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT LH</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>02P4001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T09:00:39.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740131616</udiDi>
    <basicUdiDi>038074AIP0749LN</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i FSH</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07P4901</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T07:21:51.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740131494</udiDi>
    <basicUdiDi>038074AIP0795LV</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i Total T4</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07P9501</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T07:21:48.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740131456</udiDi>
    <basicUdiDi>038074AIP0765LL</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i Ferritin Reagent Kit</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07P6501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T07:21:48.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740131128</udiDi>
    <basicUdiDi>038074AIP0748LL</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i TSH Reagent Kit</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07P4801</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T07:21:42.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740131081</udiDi>
    <basicUdiDi>038074AIP0769LU</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i Free T3 Reagent Kit</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07P6901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T07:21:41.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740130541</udiDi>
    <basicUdiDi>038074AIP0794LT</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i Total T3</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07P9401</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T07:21:37.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740121792</udiDi>
    <basicUdiDi>038074AIP0770LD</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity Free T4</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07P7001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T07:20:32.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740121488</udiDi>
    <basicUdiDi>038074AIP0751L9</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i Total B-hCG</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07P5101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T07:20:31.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740121556</udiDi>
    <basicUdiDi>038074AIP0766LN</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i Prolactin</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07P6601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T07:20:29.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740121907</udiDi>
    <basicUdiDi>038074AIP0845LK</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i 25-OH Vitamin D Reagent Kit</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>08P4501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T05:59:48.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740121853</udiDi>
    <basicUdiDi>038074AIP0836LJ</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i Progesterone</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>08P3601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T05:59:46.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014889</udiDi>
    <basicUdiDi>038074EAK0777HY</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT Progesterone</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07K7701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T05:59:42.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740001858</udiDi>
    <basicUdiDi>038074LGF0009LS</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT Urine NGAL</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152208</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01P3701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T05:58:38.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740144791</udiDi>
    <basicUdiDi>038074ARK0763NE</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>Architect Free T3</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07K6302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T04:40:58.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740129453</udiDi>
    <basicUdiDi>038074ARK0766NL</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT Total T4</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07K6602</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T04:39:59.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014933</udiDi>
    <basicUdiDi>038074AIK0778K6</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT BHCG</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07K7801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T04:39:58.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014834</udiDi>
    <basicUdiDi>038074ARK0776NP</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT Prolactin</deviceName>
    <manufacturerName>Abbott Ireland Diagnostics Division</manufacturerName>
    <manufacturerSrn>IE-MF-000010070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>07K7601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T04:39:56.630Z</lastUpdated>
  </row>
</eudamedExport>