<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <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>05032384514359</udiDi>
    <basicUdiDi>5032384OxidaseStripsVH</basicUdiDi>
    <tradeName>OXIDASE STRIPS</tradeName>
    <deviceName>OXIDASE STRIPS</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB0266B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384533121</udiDi>
    <basicUdiDi>5032384AztreonAvibact3E</basicUdiDi>
    <tradeName>AZA50 AZTREONAM / AVIBACTAM</tradeName>
    <deviceName>AZTREONAM / AVIBACTAM</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT1971B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:44.826Z</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>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>
  <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>2026-07-31T10:06:44.197Z</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>2026-07-31T10:06:43.977Z</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>2026-07-31T10:06:43.938Z</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>2026-07-31T10:06:43.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643902244</udiDi>
    <basicUdiDi>59026439BASTTYNT</basicUdiDi>
    <tradeName>05902643902244</tradeName>
    <deviceName>TYLOSIN 30 (B) E112015</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E112015 (B)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:04:37.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643901711</udiDi>
    <basicUdiDi>59026439BASTTSNF</basicUdiDi>
    <tradeName>05902643901711</tradeName>
    <deviceName>TRIMETHOPRIM SULPHADIAZINE 30 (B) E191833</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E191833 (B)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:04:36.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643901681</udiDi>
    <basicUdiDi>59026439BASTTMOTD</basicUdiDi>
    <tradeName>05902643901681</tradeName>
    <deviceName>TEMOCILLIN 30 (B) E112038</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E112038 (B)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:04:35.357Z</lastUpdated>
  </row>
</eudamedExport>