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<eudamedExport entity="devices">
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    <udiDi>05056080500003</udiDi>
    <basicUdiDi>50560805PathoDXHerpesW5</basicUdiDi>
    <tradeName>PATHODX HERPES TYPING KIT</tradeName>
    <deviceName>PATHODX HERPES TYPING KIT</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040301</emdnCode>
    <emdnDescription>HSV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:10.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384519910</udiDi>
    <basicUdiDi>50560805ImagenTefSlide2F</basicUdiDi>
    <tradeName>IMAGEN TEFLON COATED SLIDES (100/BOX)</tradeName>
    <deviceName>IMAGEN TEFLON COATED SLIDES</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>W0503900201</emdnCode>
    <emdnDescription>MICROSCOPE SLIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S611430-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:44:25.918Z</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>2026-07-01T22:28:56.856Z</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>05032384519897</udiDi>
    <basicUdiDi>5032384PathoDxtraPCFJ</basicUdiDi>
    <tradeName>PATHODXTRA POSITIVE CONTROL</tradeName>
    <deviceName>PATHODXTRA POSITIVE CONTROL</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0707G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:53.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384519835</udiDi>
    <basicUdiDi>5032384PathoDxtraLatexTL</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUP A LATEX</tradeName>
    <deviceName>PATHODXTRA STREP GROUP LATEX</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0701G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:52.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384519828</udiDi>
    <basicUdiDi>5032384ProSpecTWashDM</basicUdiDi>
    <tradeName>PROSPECT WASH BUFFER</tradeName>
    <deviceName>PROSPECT WASH BUFFER</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>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R2450001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:52.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384519606</udiDi>
    <basicUdiDi>5032384PathoDxtraCardG8</basicUdiDi>
    <tradeName>PATHODXTRA DISPOSABLE CARDS</tradeName>
    <deviceName>PATHODXTRA DISPOSABLE CARDS</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0720G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:51.240Z</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>2026-07-01T22:28:50.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384519576</udiDi>
    <basicUdiDi>5032384PathoDxtraRSetHV</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUPING REAGENT SET</tradeName>
    <deviceName>PATHODXTRA STREP GROUPING REAGENT SET</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0710M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:49.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384519569</udiDi>
    <basicUdiDi>5032384PathoDxtraReagJQ</basicUdiDi>
    <tradeName>PATHODXTRA EXTRACTION REAGENTS</tradeName>
    <deviceName>PATHODXTRA EXTRACTION REAGENTS</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0709M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:48.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384519552</udiDi>
    <basicUdiDi>5032384PathoDxtraStrepZC</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUPING KIT</tradeName>
    <deviceName>PATHODXTRA STREP GROUPING KIT</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0700M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:48.038Z</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>05032384503940</udiDi>
    <basicUdiDi>5032384PSCrypto43</basicUdiDi>
    <tradeName>PROSPECT CRYPTOSPORIDIUM MICROPLATE ASSAY</tradeName>
    <deviceName>PROSPECT CRYPTOSPORIDIUM MICROPLATE ASSAY</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>W0104050203</emdnCode>
    <emdnDescription>CRYPTOSPORIDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R2454096</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:44.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384503926</udiDi>
    <basicUdiDi>5032384PSGardiaSF</basicUdiDi>
    <tradeName>PROSPECT GIARDIA MICROPLATE ASSAY</tradeName>
    <deviceName>PROSPECT GIARDIA MICROPLATE ASSAY</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>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R2458096</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:44.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384501755</udiDi>
    <basicUdiDi>5032384SeleniteBrothOL2L2</basicUdiDi>
    <tradeName>SELENITE F BROTH</tradeName>
    <deviceName>SELENITE F BROTH</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>W0104010306</emdnCode>
    <emdnDescription>CULTURE MEDIA IN BOTTLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB1321E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:43.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384499113</udiDi>
    <basicUdiDi>5032384TemocillinPY</basicUdiDi>
    <tradeName>TEM30 TEMOCILLIN</tradeName>
    <deviceName>TEMOCILLIN</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>CT1952B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:28:42.442Z</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>
</eudamedExport>