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<eudamedExport entity="devices">
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    <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>2026-07-31T10:07:08.403Z</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>2026-07-31T10:07:08.064Z</lastUpdated>
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  <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>2026-07-31T10:06:45.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384533916</udiDi>
    <basicUdiDi>5032384DKMGNQE</basicUdiDi>
    <tradeName>SENSITITRE DKMGN</tradeName>
    <deviceName>SENSITITRE DKMGN</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>DKMGN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:44.781Z</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>2026-07-31T10:06:44.740Z</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>2026-07-31T10:06:44.640Z</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>2026-07-31T10:06:44.579Z</lastUpdated>
  </row>
  <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>2026-07-31T10:06:44.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384547944</udiDi>
    <basicUdiDi>5032384FRAM2GNKZ</basicUdiDi>
    <tradeName>SENSITITRE FRAM2GN</tradeName>
    <deviceName>SENSITITRE FRAM2GN</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>FRAM2GN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:44.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384547968</udiDi>
    <basicUdiDi>5032384FRAM1GNKU</basicUdiDi>
    <tradeName>SENSITITRE FRAM1GN</tradeName>
    <deviceName>SENSITITRE FRAM1GN</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>FRAM1GN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:44.525Z</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>2026-07-31T10:06:44.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384549344</udiDi>
    <basicUdiDi>5032384BEGNUZ3LC</basicUdiDi>
    <tradeName>SENSITITRE BEGNUZ3</tradeName>
    <deviceName>SENSITITRE BEGNUZ3</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>BEGNUZ3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:44.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384549368</udiDi>
    <basicUdiDi>5032384BEGNUZLB</basicUdiDi>
    <tradeName>SENSITITRE BEGNUZ</tradeName>
    <deviceName>SENSITITRE BEGNUZ</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>BEGNUZ</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:44.464Z</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>2026-07-31T10:06:44.256Z</lastUpdated>
  </row>
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    <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>2026-07-31T10:06:44.197Z</lastUpdated>
  </row>
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    <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>2026-07-31T10:06:43.977Z</lastUpdated>
  </row>
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    <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>2026-07-31T10:06:43.938Z</lastUpdated>
  </row>
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    <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>2026-07-31T10:06:43.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384524433</udiDi>
    <basicUdiDi>5032384ITAMYUCC4M</basicUdiDi>
    <tradeName>SENSITITRE YEASTONE ITAMYUCC</tradeName>
    <deviceName>SENSITITRE ITAMYUCC</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>ITAMYUCC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:55:53.599Z</lastUpdated>
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</eudamedExport>