<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05032384547845</udiDi>
    <basicUdiDi>5032384SensititreFRCOLKC</basicUdiDi>
    <tradeName>SENSITITRE FRCOL</tradeName>
    <deviceName>SENSITITRE FRCOL</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080599</emdnCode>
    <emdnDescription>MANUAL SUSCEPTIBILITY TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRCOL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:56.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384546534</udiDi>
    <basicUdiDi>5032384SEMEDLQN</basicUdiDi>
    <tradeName>SENSITITRE SEMEDL</tradeName>
    <deviceName>SENSITITRE SEMEDL</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080599</emdnCode>
    <emdnDescription>MANUAL SUSCEPTIBILITY TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEMEDL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:56.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384545872</udiDi>
    <basicUdiDi>5032384SensititreARISHQ2V</basicUdiDi>
    <tradeName>SENSITITRE ARIS HIQ SYSTEM</tradeName>
    <deviceName>SENSITITRE ARIS HIQ SYSTEM</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V4000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:55.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384533930</udiDi>
    <basicUdiDi>5032384SensititreEUGNFKT</basicUdiDi>
    <tradeName>SENSITITRE EUGNF</tradeName>
    <deviceName>SENSITITRE EUGNF</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUGNF</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:54.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384506910</udiDi>
    <basicUdiDi>5032384SensititreGN6F77</basicUdiDi>
    <tradeName>SENSITITRE GN6F</tradeName>
    <deviceName>SENSITITRE GN6F</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN6F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:45.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384497409</udiDi>
    <basicUdiDi>5032384SensititreAIM4S</basicUdiDi>
    <tradeName>SENSITITRE AIM</tradeName>
    <deviceName>SENSITITRE AIM</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039099</emdnCode>
    <emdnDescription>VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V3020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:41.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384474530</udiDi>
    <basicUdiDi>5032384SensititreOptiR58</basicUdiDi>
    <tradeName>SENSITITRE OPTIREAD</tradeName>
    <deviceName>SENSITITRE OPTIREAD</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V3030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:40.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384474516</udiDi>
    <basicUdiDi>5032384SensititreNephelSJ</basicUdiDi>
    <tradeName>SENSITITRE NEPHELOMETER</tradeName>
    <deviceName>SENSITITRE NEPHELOMETER</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039099</emdnCode>
    <emdnDescription>VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V3011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:39.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384474509</udiDi>
    <basicUdiDi>5032384SensititreVizion2N</basicUdiDi>
    <tradeName>SENSITITRE VIZION</tradeName>
    <deviceName>SENSITITRE VIZION</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V2021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:38.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384474363</udiDi>
    <basicUdiDi>5032384SensititreGPID93</basicUdiDi>
    <tradeName>SENSITITRE GPID</tradeName>
    <deviceName>SENSITITRE GPID</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080103</emdnCode>
    <emdnDescription>GRAM POSITIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GPID</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:37.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384474325</udiDi>
    <basicUdiDi>5032384SensititreGNID8R</basicUdiDi>
    <tradeName>SENSITITRE GNID</tradeName>
    <deviceName>SENSITITRE GNID</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080101</emdnCode>
    <emdnDescription>GRAM NEGATIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GNID</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:36.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384474318</udiDi>
    <basicUdiDi>5032384SensititreGN4F6Z</basicUdiDi>
    <tradeName>SENSITITRE GN4F</tradeName>
    <deviceName>SENSITITRE GN4F</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN4F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:36.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384474288</udiDi>
    <basicUdiDi>5032384SensititreESB1FFY</basicUdiDi>
    <tradeName>SENSITITRE ESB1F</tradeName>
    <deviceName>SENSITITRE ESB1F</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESB1F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:35.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384436835</udiDi>
    <basicUdiDi>5032384SensititreYO109H</basicUdiDi>
    <tradeName>SENSITITRE YEASTONE YO10</tradeName>
    <deviceName>SENSITITRE YEASTONE YO10</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010403060101</emdnCode>
    <emdnDescription>SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - MANUAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YO10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:33.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384584468</udiDi>
    <basicUdiDi>5032384EUENC2FNE</basicUdiDi>
    <tradeName>SENSITITRE EUENC2F</tradeName>
    <deviceName>SENSITITRE EUENC2F</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080108</emdnCode>
    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUENC2F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:24:47.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384584451</udiDi>
    <basicUdiDi>5032384EUSTA2FU8</basicUdiDi>
    <tradeName>SENSITITRE EUSTA2F</tradeName>
    <deviceName>SENSITITRE EUSTA2F</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080108</emdnCode>
    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUSTA2F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:24:46.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384581245</udiDi>
    <basicUdiDi>5032384LCNURGN1ZK</basicUdiDi>
    <tradeName>SENSITITRE LCNURGN1</tradeName>
    <deviceName>SENSITITRE LCNURGN1</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LCNURGN1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:24:45.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384565726</udiDi>
    <basicUdiDi>5032384NONAG8XTB</basicUdiDi>
    <tradeName>SENSITITRE NONAG8X</tradeName>
    <deviceName>SENSITITRE NONAG8X</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080599</emdnCode>
    <emdnDescription>MANUAL SUSCEPTIBILITY TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NONAG8X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:24:44.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384565320</udiDi>
    <basicUdiDi>5032384FRCERGN1TZ</basicUdiDi>
    <tradeName>SENSITITRE FRCERGN1</tradeName>
    <deviceName>SENSITITRE FRCERGN1</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080599</emdnCode>
    <emdnDescription>MANUAL SUSCEPTIBILITY TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRCERGN1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:24:44.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384548156</udiDi>
    <basicUdiDi>5032384EURGNCOL44</basicUdiDi>
    <tradeName>SENSITITRE EURGNCOL</tradeName>
    <deviceName>SENSITITRE EURGNCOL</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080599</emdnCode>
    <emdnDescription>MANUAL SUSCEPTIBILITY TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EURGNCOL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:24:42.525Z</lastUpdated>
  </row>
</eudamedExport>