<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00380740014780</udiDi>
    <basicUdiDi>038074ARK0775NM</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT 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>07K7501</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T04:39:54.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014360</udiDi>
    <basicUdiDi>038074ARK0765NJ</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT 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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07K6510</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T04:39:50.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014346</udiDi>
    <basicUdiDi>038074ARK0764NG</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT 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>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07K6450</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T04:39:47.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014209</udiDi>
    <basicUdiDi>038074ARK0762NC</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>Architect TSH</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>07K6201</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-09-23T04:38:55.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014070</udiDi>
    <basicUdiDi>038074ARK0759NP</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT Ferritin</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>07K5901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T04:38:54.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740130626</udiDi>
    <basicUdiDi>038074AIP0814L8</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i Folate</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>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08P1542</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T03:30:39.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740130718</udiDi>
    <basicUdiDi>038074AIP0813L6</basicUdiDi>
    <tradeName>Alinity</tradeName>
    <deviceName>Alinity i STAT High Sensitive Troponin-I Reagent Kit</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>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08P1301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T03:30:37.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740117948</udiDi>
    <basicUdiDi>038074ARP0325P9</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT STAT High Sensitive Troponin-I</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>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03P2502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T03:30:36.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740116415</udiDi>
    <basicUdiDi>038074ARP0502P7</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>Architect 25-0H Vitamin D</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>05P0201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T03:29:41.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740002084</udiDi>
    <basicUdiDi>038074ARP0174PC</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName>ARCHITECT Folate</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>01P7401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-23T03:29:38.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740002176</udiDi>
    <basicUdiDi>038074ARP0174PC</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>01P7450</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:04:57.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740001872</udiDi>
    <basicUdiDi>038074LGF0009LS</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>01P3725</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:04:57.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014087</udiDi>
    <basicUdiDi>038074ARK0759NP</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>07K5910</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:45.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014216</udiDi>
    <basicUdiDi>038074ARK0762NC</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>07K6210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:44.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014100</udiDi>
    <basicUdiDi>038074ARK0759NP</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>07K5925</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:44.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014230</udiDi>
    <basicUdiDi>038074ARK0762NC</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>07K6225</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:28.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740002169</udiDi>
    <basicUdiDi>038074ARP0174PC</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>01P7440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:28.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740002121</udiDi>
    <basicUdiDi>038074ARP0174PC</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>01P7425</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:28.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740006334</udiDi>
    <basicUdiDi>038074ARP0174PC</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>03P2160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:28.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740014247</udiDi>
    <basicUdiDi>038074ARK0762NC</basicUdiDi>
    <tradeName>ARCHITECT</tradeName>
    <deviceName></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>07K6230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:28.189Z</lastUpdated>
  </row>
</eudamedExport>