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<eudamedExport entity="devices">
  <row>
    <udiDi>00842558106939</udiDi>
    <basicUdiDi>8488380M4RTKitEB</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) FLOCKED SWAB KIT PK/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12588</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:36.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842558107004</udiDi>
    <basicUdiDi>8488380M4RTA3</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) TUBE PK/72</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12587</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:36.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842558108919</udiDi>
    <basicUdiDi>8488380M4RTA3</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) W/O BEADS TUBE, RED PK/72</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:36.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842558109527</udiDi>
    <basicUdiDi>8488380M4RTKitEB</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) W/O BEADS NP SWAB KIT PK/ 100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12705</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:36.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842558109718</udiDi>
    <basicUdiDi>8488380M4RTKitEB</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) DUAL SWAB KIT PK/72</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:36.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838011177</udiDi>
    <basicUdiDi>8488380DeminWaterUP</basicUdiDi>
    <tradeName>SENSITITRE DEMINERALIZED WATER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T3339</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838018336</udiDi>
    <basicUdiDi>8488380M4RTA3</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) TUBE, RED PK/72</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12505</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838018350</udiDi>
    <basicUdiDi>8488380M5Y4</basicUdiDi>
    <tradeName>MICROTEST M5 (3 ML) PK/72</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12515</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838018411</udiDi>
    <basicUdiDi>8488380M4RTKitEB</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) TRADITIONAL SWAB KIT PK/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12552</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838018442</udiDi>
    <basicUdiDi>8488380M5KitA2</basicUdiDi>
    <tradeName>MICROTEST M5 (3 ML) TRADITIONAL SWAB KIT PK/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12555</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838018534</udiDi>
    <basicUdiDi>8488380M4RTKitEB</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) UNIVERSAL SWAB KIT PK/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12578</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838018558</udiDi>
    <basicUdiDi>8488380M5KitA2</basicUdiDi>
    <tradeName>MICROTEST M5 (3 ML) UNIVERSAL SWAB KIT PK/100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12580</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838020667</udiDi>
    <basicUdiDi>8488380DeminWaterUP</basicUdiDi>
    <tradeName>SENSITITRE DEMINERALIZED WATER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T3339-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022227</udiDi>
    <basicUdiDi>8488380CoagulasePlasmaLJ</basicUdiDi>
    <tradeName>COAGULASE PLASMA 5ML</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022241</udiDi>
    <basicUdiDi>8488380CoagulasePlasmaLJ</basicUdiDi>
    <tradeName>COAGULASE PLASMA 15ML</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21051</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022258</udiDi>
    <basicUdiDi>8488380CoagulasePlasmaLJ</basicUdiDi>
    <tradeName>COAGULASE PLASMA 25ML</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21052</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022265</udiDi>
    <basicUdiDi>8488380CoagulasePlasmaLJ</basicUdiDi>
    <tradeName>COAGULASE PLASMA 5ML PK/6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022333</udiDi>
    <basicUdiDi>8488380HippurateDiskTV</basicUdiDi>
    <tradeName>HIPPURATE DISK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21085</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022432</udiDi>
    <basicUdiDi>8488380BactiCardCandida8B</basicUdiDi>
    <tradeName>BACTICARD CANDIDA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022456</udiDi>
    <basicUdiDi>8488380BctCrdEcoliHQ</basicUdiDi>
    <tradeName>BACTICARD E. COLI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GRAM NEGATIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.383Z</lastUpdated>
  </row>
</eudamedExport>