<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-C80306VL</udiDi>
    <basicUdiDi>B-C80306VL</basicUdiDi>
    <tradeName>MicroScan Neg MDR Combo 100</tradeName>
    <deviceName>MicroScan Neg MDR Combo 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80306</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:20.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C80305VJ</udiDi>
    <basicUdiDi>B-C80305VJ</basicUdiDi>
    <tradeName>MicroScan Neg Breakpoint Combo 53</tradeName>
    <deviceName>MicroScan Neg Breakpoint Combo 53</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80305</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:19.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C80304VG</udiDi>
    <basicUdiDi>B-C80304VG</basicUdiDi>
    <tradeName>MicroScan Neg Combo 99</tradeName>
    <deviceName>MicroScan Neg Combo 99</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80304</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:15.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C80303VE</udiDi>
    <basicUdiDi>B-C80303VE</basicUdiDi>
    <tradeName>MicroScan Neg Urine Combo Panel Type 98</tradeName>
    <deviceName>MicroScan Neg Urine Combo Panel Type 98</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80303</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:14.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C80302VC</udiDi>
    <basicUdiDi>B-C80302VC</basicUdiDi>
    <tradeName>MicroScan Neg Multidrug Resistant MIC 2</tradeName>
    <deviceName>MicroScan Neg Multidrug Resistant MIC 2</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80302</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:13.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C80301VA</udiDi>
    <basicUdiDi>B-C80301VA</basicUdiDi>
    <tradeName>MicroScan Negative MIC NF 64</tradeName>
    <deviceName>MicroScan Negative MIC NF 64</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80301</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:13.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C80300V8</udiDi>
    <basicUdiDi>B-C80300V8</basicUdiDi>
    <tradeName>MicroScan Neg MIC Panel Type 63</tradeName>
    <deviceName>MicroScan Neg MIC Panel Type 63</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80300</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:09.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C80299WG</udiDi>
    <basicUdiDi>B-C80299WG</basicUdiDi>
    <tradeName>MicroScan Neg MIC Panel Type 62</tradeName>
    <deviceName>MicroScan Neg MIC Panel Type 62</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C80299</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:08.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C54389WD</udiDi>
    <basicUdiDi>B-C54389WD</basicUdiDi>
    <tradeName>HighFlexx v2.9 (MR)</tradeName>
    <deviceName>HighFlexx v2.9 (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>W0203010182</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C54389</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:02.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C38722W7</udiDi>
    <basicUdiDi>B-C38722W7</basicUdiDi>
    <tradeName>LabPro Connect v5.0 System DVD Kit (FMR)</tradeName>
    <deviceName>LabPro Connect v5.0 System DVD Kit (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>W0203010182</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C38722</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:43.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C38721W5</udiDi>
    <basicUdiDi>B-C38721W5</basicUdiDi>
    <tradeName>LabPro v5.0 System DVD Kit (FMR)</tradeName>
    <deviceName>LabPro v5.0 System DVD Kit (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>W0203010182</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C38721</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:42.660Z</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-C38213VD</udiDi>
    <basicUdiDi>B-C38213VD</basicUdiDi>
    <tradeName>MicroScan MSF Neg/Pos ID Panel Type 2</tradeName>
    <deviceName>MicroScan MSF Neg/Pos ID Panel Type 2</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C38213</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:36.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C32700UK</udiDi>
    <basicUdiDi>B-C32700UK</basicUdiDi>
    <tradeName>MicroScan MSF FAST MIC Panel Type 2</tradeName>
    <deviceName>MicroScan MSF FAST MIC Panel Type 2</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C32700</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:30.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C32699VT</udiDi>
    <basicUdiDi>B-C32699VT</basicUdiDi>
    <tradeName>MicroScan MSF Neg MIC Panel Type 2</tradeName>
    <deviceName>MicroScan MSF Neg MIC Panel Type 2</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C32699</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:29.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C32698VR</udiDi>
    <basicUdiDi>B-C32698VR</basicUdiDi>
    <tradeName>MicroScan MSF Pos MIC Panel Type 2</tradeName>
    <deviceName>MicroScan MSF Pos MIC Panel Type 2</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C32698</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:29.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C32368UZ</udiDi>
    <basicUdiDi>B-C32368UZ</basicUdiDi>
    <tradeName>MicroScan Neg Multidrug Resistant MIC 1</tradeName>
    <deviceName>MicroScan Neg Multidrug Resistant MIC 1</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C32368</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:28.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C24166UN</udiDi>
    <basicUdiDi>B-C24166UN</basicUdiDi>
    <tradeName>Labpro v5.0 System (MR)</tradeName>
    <deviceName>Labpro v5.0 System (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>W0203010182</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C24166</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:17.853Z</lastUpdated>
  </row>
</eudamedExport>