<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>15099590656409</udiDi>
    <basicUdiDi>15099501MCOVPOSSN</basicUdiDi>
    <tradeName>MicroScan Pos Breakpoint Combo Panel Type 28</tradeName>
    <deviceName>MicroScan Pos MIC/Combo Panel Family</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1016-138</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:30:07.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590656393</udiDi>
    <basicUdiDi>15099501MCOVNEGQN</basicUdiDi>
    <tradeName>MicroScan Neg Breakpoint Combo Panel Type 42</tradeName>
    <deviceName>MicroScan Neg MIC/Combo Panel Family</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1016-137</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:30:06.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590655754</udiDi>
    <basicUdiDi>15099501MCBROTHLX</basicUdiDi>
    <tradeName>MicroScan MH BROTH with 3% LHB</tradeName>
    <deviceName>MicroScan Broth Family</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1015-25</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:30:02.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590655662</udiDi>
    <basicUdiDi>15099501MCWATERQF</basicUdiDi>
    <tradeName>MicroScan 0.4% Saline with PLURONIC</tradeName>
    <deviceName>MicroScan Inoculum Family</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1015-11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:30:01.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590655532</udiDi>
    <basicUdiDi>15099501MCRENOKP6</basicUdiDi>
    <tradeName>MicroScan RENOK Disposable D-Inoculator Sets</tradeName>
    <deviceName>MicroScan RENOK Rehydrating/Inoculating System</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1013-4</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:30:00.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590655402</udiDi>
    <basicUdiDi>15099501MCHNIDFY</basicUdiDi>
    <tradeName>MicroScan HNID Panel</tradeName>
    <deviceName>MicroScan HNID Panel</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>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1012-10B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:29:59.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590655266</udiDi>
    <basicUdiDi>15099501MCACSRYJT</basicUdiDi>
    <tradeName>MicroScan Seal Strips</tradeName>
    <deviceName>MicroScan Product Accessories</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1010-51</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:29:55.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590655181</udiDi>
    <basicUdiDi>15099501MCRGNTJJ</basicUdiDi>
    <tradeName>MicroScan Mineral Oil</tradeName>
    <deviceName>MicroScan Reagent Family</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B1010-40</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:29:55.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973049099059</udiDi>
    <basicUdiDi>697304909Model97V7</basicUdiDi>
    <tradeName>Autof ms2600</tradeName>
    <deviceName>Automated Mass Spectrometry Microbial Identification System</deviceName>
    <manufacturerName>Autobio Labtec Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012110</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020303</emdnCode>
    <emdnDescription>MASS - SPECTROMETRY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01106</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:50.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973049099042</udiDi>
    <basicUdiDi>697304909Model96V5</basicUdiDi>
    <tradeName>Autof ms1600</tradeName>
    <deviceName>Automated Mass Spectrometry Microbial Identification System</deviceName>
    <manufacturerName>Autobio Labtec Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012110</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020303</emdnCode>
    <emdnDescription>MASS - SPECTROMETRY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01105</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:44.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973049099035</udiDi>
    <basicUdiDi>697304909Model95V3</basicUdiDi>
    <tradeName>Autof ms800</tradeName>
    <deviceName>Automated Mass Spectrometry Microbial Identification System</deviceName>
    <manufacturerName>Autobio Labtec Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012110</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020303</emdnCode>
    <emdnDescription>MASS - SPECTROMETRY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01104</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:43.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973049099028</udiDi>
    <basicUdiDi>697304909Model94UZ</basicUdiDi>
    <tradeName>Autof ms600</tradeName>
    <deviceName>Automated Mass Spectrometry Microbial Identification System</deviceName>
    <manufacturerName>Autobio Labtec Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012110</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020303</emdnCode>
    <emdnDescription>MASS - SPECTROMETRY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01103</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:41.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973049099011</udiDi>
    <basicUdiDi>697304909Model93UX</basicUdiDi>
    <tradeName>Autof ms2000</tradeName>
    <deviceName>Automated Mass Spectrometry Microbial Identification System</deviceName>
    <manufacturerName>Autobio Labtec Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012110</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020303</emdnCode>
    <emdnDescription>MASS - SPECTROMETRY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01102</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:39.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973049099004</udiDi>
    <basicUdiDi>697304909Model90UR</basicUdiDi>
    <tradeName>Autof ms1000</tradeName>
    <deviceName>Automated Mass Spectrometry  Microbial Identification System</deviceName>
    <manufacturerName>Autobio Labtec Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012110</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020303</emdnCode>
    <emdnDescription>MASS - SPECTROMETRY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01101</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:34.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053062237</udiDi>
    <basicUdiDi>69449040AB41000022E</basicUdiDi>
    <tradeName>Automated ID/AST Testing System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-360</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:29.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053062244</udiDi>
    <basicUdiDi>69449040AB41000022E</basicUdiDi>
    <tradeName>Automated ID/AST Testing System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:29.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053062251</udiDi>
    <basicUdiDi>69449040AB41000022E</basicUdiDi>
    <tradeName>Automated ID/AST Testing System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-660</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:29.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053070447</udiDi>
    <basicUdiDi>69449040AB41000032G</basicUdiDi>
    <tradeName>Automated Blood Culture System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA-N60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053070454</udiDi>
    <basicUdiDi>69449040AB41000032G</basicUdiDi>
    <tradeName>Automated Blood Culture System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA-N240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053147057</udiDi>
    <basicUdiDi>69449040AB41000032G</basicUdiDi>
    <tradeName>Automated Blood Culture System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA-N20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:10:13.397Z</lastUpdated>
  </row>
</eudamedExport>