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<eudamedExport entity="devices">
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    <udiDi>00848838023828</udiDi>
    <basicUdiDi>8488380BDrpKOHQG</basicUdiDi>
    <tradeName>BACTIDROP KOH (10%)</tradeName>
    <deviceName>BACTIDROP KOH</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>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21524</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:50.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023811</udiDi>
    <basicUdiDi>8488380BDrpIndoleKovP2</basicUdiDi>
    <tradeName>BACTIDROP INDOLE (KOVACS)</tradeName>
    <deviceName>BACTIDROP INDOLE (KOVACS)</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>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21522</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:47.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023798</udiDi>
    <basicUdiDi>8488380BDrpIndiaInkRV</basicUdiDi>
    <tradeName>BACTIDROP INDIA INK</tradeName>
    <deviceName>BACTIDROP INDIA INK</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>IVDR 2017/746</legislation>
    <emdnCode>W0104010804</emdnCode>
    <emdnDescription>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21518</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:45.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023781</udiDi>
    <basicUdiDi>8488380BDrpFeChlorideXU</basicUdiDi>
    <tradeName>BACTIDROP FERRIC CHLORIDE (10%)</tradeName>
    <deviceName>BACTIDROP FERRIC CHLORIDE</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>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21514</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:43.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023767</udiDi>
    <basicUdiDi>8488380BDrpDesoxychocZ6</basicUdiDi>
    <tradeName>BACTIDROP DESOXYCHOLATE (10%)</tradeName>
    <deviceName>BACTIDROP DESOXYCHOLATE</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>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21508</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:42.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023774</udiDi>
    <basicUdiDi>8488380BDrpDOCIodineB7</basicUdiDi>
    <tradeName>BACTIDROP DOBELL and O'CONNOR IODINE</tradeName>
    <deviceName>BACTIDROP DOBELL and O'CONNOR IODINE</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>IVDR 2017/746</legislation>
    <emdnCode>W0104010804</emdnCode>
    <emdnDescription>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21510</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:41.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023743</udiDi>
    <basicUdiDi>8488380BDrpAcridOrangeGM</basicUdiDi>
    <tradeName>BACTIDROP ACRIDINE ORANGE</tradeName>
    <deviceName>BACTIDROP ACRIDINE ORANGE</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>IVDR 2017/746</legislation>
    <emdnCode>W0104010804</emdnCode>
    <emdnDescription>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:39.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023750</udiDi>
    <basicUdiDi>8488380BDrpCalcoFWhite5G</basicUdiDi>
    <tradeName>BACTIDROP CALCOFLUOR WHITE</tradeName>
    <deviceName>BACTIDROP CALCOFLUOR WHITE</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>IVDR 2017/746</legislation>
    <emdnCode>W0104010804</emdnCode>
    <emdnDescription>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21507</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:36.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023088</udiDi>
    <basicUdiDi>8488380NitrocefinDisk47</basicUdiDi>
    <tradeName>NITROCEFIN DISK</tradeName>
    <deviceName>NITROCEFIN DISK</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>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R211667</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:22.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022746</udiDi>
    <basicUdiDi>8488380MicrodaseDiskAG</basicUdiDi>
    <tradeName>MICRODASE DISK</tradeName>
    <deviceName>MICRODASE DISK</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>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21132</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:21.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022593</udiDi>
    <basicUdiDi>8488380CatarrhalisDiskQM</basicUdiDi>
    <tradeName>CATARRHALIS TEST DISK</tradeName>
    <deviceName>CATARRHALIS TEST DISK</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>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21121</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:18.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022470</udiDi>
    <basicUdiDi>8488380BctCrdNeisseriaBV</basicUdiDi>
    <tradeName>BACTICARD NEISSERIA</tradeName>
    <deviceName>BACTICARD NEISSERIA</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>IVDR 2017/746</legislation>
    <emdnCode>W0104080201</emdnCode>
    <emdnDescription>GRAM NEGATIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21110</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:15.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022456</udiDi>
    <basicUdiDi>8488380BctCrdEcoliHQ</basicUdiDi>
    <tradeName>BACTICARD E. COLI</tradeName>
    <deviceName>BACTICARD E. COLI</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>IVDR 2017/746</legislation>
    <emdnCode>W0104080201</emdnCode>
    <emdnDescription>GRAM NEGATIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21108</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:14.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022432</udiDi>
    <basicUdiDi>8488380BactiCardCandida8B</basicUdiDi>
    <tradeName>BACTICARD CANDIDA</tradeName>
    <deviceName>BACTICARD CANDIDA</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>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21106</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:10.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022333</udiDi>
    <basicUdiDi>8488380HippurateDiskTV</basicUdiDi>
    <tradeName>HIPPURATE DISK</tradeName>
    <deviceName>HIPPURATE DISK</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>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21085</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:09.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022227</udiDi>
    <basicUdiDi>8488380CoagulasePlasmaLJ</basicUdiDi>
    <tradeName>COAGULASE PLASMA 5ML</tradeName>
    <deviceName>COAGULASE PLASMA</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>IVDR 2017/746</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21050</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:08.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838018442</udiDi>
    <basicUdiDi>8488380M5KitA2</basicUdiDi>
    <tradeName>MICROTEST M5 (3 ML) TRADITIONAL SWAB KIT PK/100</tradeName>
    <deviceName>MICROTEST M5 KIT</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>IVDR 2017/746</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12555</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:06.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838018350</udiDi>
    <basicUdiDi>8488380M5Y4</basicUdiDi>
    <tradeName>MICROTEST M5 (3 ML) PK/72</tradeName>
    <deviceName>MICROTEST M5</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>IVDR 2017/746</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12515</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:04.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838011177</udiDi>
    <basicUdiDi>8488380DeminWaterUP</basicUdiDi>
    <tradeName>SENSITITRE DEMINERALIZED WATER</tradeName>
    <deviceName>SENSITITRE DEMINERALIZED WATER</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>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T3339</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:02.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842558107004</udiDi>
    <basicUdiDi>8488380M4RTA3</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) TUBE PK/72</tradeName>
    <deviceName>MICROTEST M4RT</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>IVDR 2017/746</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12587</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:20:35.541Z</lastUpdated>
  </row>
</eudamedExport>