<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-PartNumberB1016-139XT</udiDi>
    <basicUdiDi>B-PartNumberB1016-139XT</basicUdiDi>
    <tradeName>MicroScan Pos Combo Panel Type 31</tradeName>
    <deviceName>MicroScan Pos Combo Panel Type 31</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1016-139</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:12:19.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C38653WD</udiDi>
    <basicUdiDi>B-C38653WD</basicUdiDi>
    <tradeName>LabPro v5.0 HelpCenter Base Content</tradeName>
    <deviceName>LabPro v5.0 HelpCenter Base Content</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C38653</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:41.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C38651W9</udiDi>
    <basicUdiDi>B-C38651W9</basicUdiDi>
    <tradeName>LabPro Connect v5.0 (FMR)</tradeName>
    <deviceName>LabPro Connect v5.0 (FMR)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C38651</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:41.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C38649WN</udiDi>
    <basicUdiDi>B-C38649WN</basicUdiDi>
    <tradeName>LabPro v5.0 (FMR)</tradeName>
    <deviceName>LabPro v5.0 (FMR)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C38649</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:37.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C24158UP</udiDi>
    <basicUdiDi>B-C24158UP</basicUdiDi>
    <tradeName>LabPro Connect v5.0 (MR)</tradeName>
    <deviceName>LabPro Connect v5.0 (MR)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C24158</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:17.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C24155UH</udiDi>
    <basicUdiDi>B-C24155UH</basicUdiDi>
    <tradeName>LabPro v5.0 (MR)</tradeName>
    <deviceName>LabPro v5.0 (MR)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C24155</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:16.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>58059796360840</udiDi>
    <basicUdiDi>805014821IP060CMDSWM02Y9</basicUdiDi>
    <tradeName>Radian Expert System</tradeName>
    <deviceName>Radian Expert System</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLAB-RADIAN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:40.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>58052870815366</udiDi>
    <basicUdiDi>805014821IP050BMDSWM02WR</basicUdiDi>
    <tradeName>SOFTWARE HALO MEASURE &amp; VISUAL</tradeName>
    <deviceName>SOFTWARE HALO MEASURE &amp; VISUAL</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLAB-SW-HALO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:39.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350144650023</udiDi>
    <basicUdiDi>735014465GT0388</basicUdiDi>
    <tradeName>QuickMIC Analyst</tradeName>
    <deviceName>QuickMIC Analyst</deviceName>
    <manufacturerName>Gradientech AB</manufacturerName>
    <manufacturerSrn>SE-MF-000017760</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41-001</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:06:48.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904726849477</udiDi>
    <basicUdiDi>59047268494ISW-2.0UM</basicUdiDi>
    <tradeName>BACTEROMIC Interpreter ISW 2.0</tradeName>
    <deviceName>BACTEROMIC Interpreter ISW 2.0</deviceName>
    <manufacturerName>BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000040114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQS-520010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:59:39.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590702786</udiDi>
    <basicUdiDi>15099501MCBSESWLF</basicUdiDi>
    <tradeName>MicroScan LabPro V5.0 System DVD Kit (US)</tradeName>
    <deviceName>Microbiology Standalone Software Products</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>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>C24162</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:30:38.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590702793</udiDi>
    <basicUdiDi>15099501MCBSESWLF</basicUdiDi>
    <tradeName>MicroScan LabPro Connect V5.0 System DVD Kit (US)</tradeName>
    <deviceName></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>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>C24163</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:49:41.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590702809</udiDi>
    <basicUdiDi>15099501MCBSESWLF</basicUdiDi>
    <tradeName>MicroScan LabPro V5.0 System DVD Kit (JP)</tradeName>
    <deviceName></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>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>C24164</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:49:41.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590702816</udiDi>
    <basicUdiDi>15099501MCBSESWLF</basicUdiDi>
    <tradeName>MicroScan LabPro Connect V5.0 System DVD Kit (JP)</tradeName>
    <deviceName></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>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>C24165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:49:41.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590702823</udiDi>
    <basicUdiDi>15099501MCBSESWLF</basicUdiDi>
    <tradeName>MicroScan LabPro V5.0 System DVD Kit (MR)</tradeName>
    <deviceName></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>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C24166</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:49:41.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590702830</udiDi>
    <basicUdiDi>15099501MCBSESWLF</basicUdiDi>
    <tradeName>MicroScan LabPro Connect V5.0 System DVD Kit (MR)</tradeName>
    <deviceName></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>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C24167</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:49:41.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590729035</udiDi>
    <basicUdiDi>15099501MCBSESWLF</basicUdiDi>
    <tradeName>MicroScan LabPro V5.0 System DVD Kit (FMR)</tradeName>
    <deviceName></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>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>C38721</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:40:12.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590729042</udiDi>
    <basicUdiDi>15099501MCBSESWLF</basicUdiDi>
    <tradeName>MicroScan LabPro Connect V5.0 System DVD Kit (FMR)</tradeName>
    <deviceName></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>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>C38722</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:40:12.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590738099</udiDi>
    <basicUdiDi>15099501MCBSESWLF</basicUdiDi>
    <tradeName>MicroScan HighFlexX Software v2.9, Electronic</tradeName>
    <deviceName></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>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C54389</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:40:11.757Z</lastUpdated>
  </row>
</eudamedExport>