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<eudamedExport entity="devices">
  <row>
    <udiDi>00848838072710</udiDi>
    <basicUdiDi>8488380M6KitA9</basicUdiDi>
    <tradeName>MICROTEST M6 (1.5 ML) UNIVERSAL SWAB KIT PK/7</tradeName>
    <deviceName>MICROTEST M6 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>R12530</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:37.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065613</udiDi>
    <basicUdiDi>8488380GrStSafranT3</basicUdiDi>
    <tradeName>GRAM SAFRANIN 250ML</tradeName>
    <deviceName>GRAM SAFARIN</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>R40058</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:23.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065590</udiDi>
    <basicUdiDi>8488380GrStIodineSM</basicUdiDi>
    <tradeName>GRAM IODINE 250ML</tradeName>
    <deviceName>GRAM 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>R40056</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:22.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065576</udiDi>
    <basicUdiDi>8488380GrStDecolGC</basicUdiDi>
    <tradeName>GRAM DECOLORIZER 250ML</tradeName>
    <deviceName>GRAM DECOLORIZER</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>R40054</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:19.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065552</udiDi>
    <basicUdiDi>8488380GrStVioletYT</basicUdiDi>
    <tradeName>GRAM CRYSTAL VIOLET 250ML</tradeName>
    <deviceName>GRAM CRYSTAL VIOLET</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>R40052</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:18.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838058547</udiDi>
    <basicUdiDi>8488380RapIDInoculFLLC</basicUdiDi>
    <tradeName>RAPID INOCULATION FLUID 1ML PK/20</tradeName>
    <deviceName>RAPID INOCULATION FLUID</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>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R8325102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:17.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838057915</udiDi>
    <basicUdiDi>8488380RapIDNitrateBSJ</basicUdiDi>
    <tradeName>RAPID NITRATE B REAGENT</tradeName>
    <deviceName>RAPID NITRATE B REAGENT</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>R8309004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:15.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838057878</udiDi>
    <basicUdiDi>8488380RapIDNitrateASG</basicUdiDi>
    <tradeName>RAPID NITRATE A REAGENT</tradeName>
    <deviceName>RAPID NITRATE A REAGENT</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>R8309003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:12.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838057830</udiDi>
    <basicUdiDi>8488380RapIDSpIndoleJT</basicUdiDi>
    <tradeName>RAPID INDOLE REAGENT</tradeName>
    <deviceName>RAPID INDOLE REAGENT</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>R8309002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:10.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838028892</udiDi>
    <basicUdiDi>8488380PYRDiskXB</basicUdiDi>
    <tradeName>PYR 50 TEST KIT</tradeName>
    <deviceName>PYR TEST 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>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30854301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:08.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838028625</udiDi>
    <basicUdiDi>8488380LAPDiskJR</basicUdiDi>
    <tradeName>LAP 50 TEST KIT</tradeName>
    <deviceName>LAP TEST 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>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30168501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:06.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023927</udiDi>
    <basicUdiDi>8488380BDrpVPBRW</basicUdiDi>
    <tradeName>BACTIDROP VOGES-PROSKAUER B</tradeName>
    <deviceName>BACTIDROP VOGES-PROSKAUER B</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>R21562</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:04.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023910</udiDi>
    <basicUdiDi>8488380BDrpVPARU</basicUdiDi>
    <tradeName>BACTIDROP VOGES-PROSKAUER A</tradeName>
    <deviceName>BACTIDROP VOGES-PROSKAUER A</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>R21560</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:03.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023903</udiDi>
    <basicUdiDi>8488380BDrpSpotIndole3C</basicUdiDi>
    <tradeName>BACTIDROP SPOT INDOLE</tradeName>
    <deviceName>BACTIDROP SPOT INDOLE</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>R21550</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:01.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023880</udiDi>
    <basicUdiDi>8488380BDrpOxidaseHR</basicUdiDi>
    <tradeName>BACTIDROP OXIDASE</tradeName>
    <deviceName>BACTIDROP OXIDASE</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>R21540</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:58.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023873</udiDi>
    <basicUdiDi>8488380BDrpNitrateB6Q</basicUdiDi>
    <tradeName>BACTIDROP NITRATE B</tradeName>
    <deviceName>BACTIDROP NITRATE B</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>R21538</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:57.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023866</udiDi>
    <basicUdiDi>8488380BDrpNitrateA6N</basicUdiDi>
    <tradeName>BACTIDROP NITRATE A</tradeName>
    <deviceName>BACTIDROP NITRATE A</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>R21536</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:56.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023859</udiDi>
    <basicUdiDi>8488380BDrpNinhydrin2Q</basicUdiDi>
    <tradeName>BACTIDROP NINHYDRIN</tradeName>
    <deviceName>BACTIDROP NINHYDRIN</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>R21534</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:54.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023842</udiDi>
    <basicUdiDi>8488380BDrpLugIodineM4</basicUdiDi>
    <tradeName>BACTIDROP LUGOL'S IODINE</tradeName>
    <deviceName>BACTIDROP LUGOL'S 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>R21528</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:52.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023835</udiDi>
    <basicUdiDi>8488380BDrpLactAniBlue83</basicUdiDi>
    <tradeName>BACTIDROP LACTOPHENOL</tradeName>
    <deviceName>BACTIDROP LACTOPHENOL</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>R21526</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:50.929Z</lastUpdated>
  </row>
</eudamedExport>