<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05032384547791</udiDi>
    <basicUdiDi>B-05032384547791</basicUdiDi>
    <tradeName>SENSITITRE FRUNIGP1</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRUNIGP1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:55:35.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384490813</udiDi>
    <basicUdiDi>B-05032384490813</basicUdiDi>
    <tradeName>SENSITITRE GPALL3F</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GPALL3F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:55:11.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384474370</udiDi>
    <basicUdiDi>B-05032384474370</basicUdiDi>
    <tradeName>SENSITITRE GPN3F</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GPN3F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:55:06.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384547555</udiDi>
    <basicUdiDi>B-05032384547555</basicUdiDi>
    <tradeName>SENSITITRE IRE2SSP</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRE2SSP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:54:46.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384547449</udiDi>
    <basicUdiDi>B-05032384547449</basicUdiDi>
    <tradeName>SENSITITRE ITGNEGF</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITGNEGF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:54:39.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384546640</udiDi>
    <basicUdiDi>B-05032384546640</basicUdiDi>
    <tradeName>SENSITITRE RAPMYCOI</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAPMYCOI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:53:08.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384546190</udiDi>
    <basicUdiDi>B-05032384546190</basicUdiDi>
    <tradeName>SENSITITRE STRHAE2</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STRHAE2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:53:05.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384546053</udiDi>
    <basicUdiDi>B-05032384546053</basicUdiDi>
    <tradeName>SENSITITRE SWE2ESB</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWE2ESB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:53:04.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384436828</udiDi>
    <basicUdiDi>B-05032384436828</basicUdiDi>
    <tradeName>SENSITITRE YO8</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YO8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:52:36.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384546381</udiDi>
    <basicUdiDi>5032384SEMSE7RP</basicUdiDi>
    <tradeName>SENSITITRE SEMSE7</tradeName>
    <deviceName>Sensititre™ SEMSE7</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>SEMSE7</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:15:49.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384565740</udiDi>
    <basicUdiDi>5032384IRBP11FKY</basicUdiDi>
    <tradeName>SENSITITRE IRBP11F</tradeName>
    <deviceName>Sensititre™ IRBP11F</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>IRBP11F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:15:48.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384545971</udiDi>
    <basicUdiDi>5032384THAPFTQ</basicUdiDi>
    <tradeName>SENSITITRE THAPF</tradeName>
    <deviceName>Sensititre™ THAPF</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>AB pazarı için değil</deviceStatus>
    <reference>THAPF</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:43:16.336Z</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>2026-07-31T10:07:08.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384474264</udiDi>
    <basicUdiDi>5032384DosingHeadBK</basicUdiDi>
    <tradeName>SENSITITRE DOSING HEADS</tradeName>
    <deviceName>SENSITITRE DOSING HEADS</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>W02039085</emdnCode>
    <emdnDescription>VARIOUS MICROBIOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E3010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:08.657Z</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>2026-07-31T10:07:08.624Z</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>2026-07-31T10:07:08.580Z</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>2026-07-31T10:07:08.540Z</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>2026-07-31T10:07:08.493Z</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>2026-07-31T10:07:08.458Z</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>2026-07-31T10:07:08.429Z</lastUpdated>
  </row>
</eudamedExport>