<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00848838023910</udiDi>
    <basicUdiDi>8488380BDrpVPARU</basicUdiDi>
    <tradeName>BACTIDROP VOGES-PROSKAUER A</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>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21560</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023927</udiDi>
    <basicUdiDi>8488380BDrpVPBRW</basicUdiDi>
    <tradeName>BACTIDROP VOGES-PROSKAUER B</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>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21562</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838028625</udiDi>
    <basicUdiDi>8488380LAPDiskJR</basicUdiDi>
    <tradeName>LAP 50 TEST KIT</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>R30168501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838028892</udiDi>
    <basicUdiDi>8488380PYRDiskXB</basicUdiDi>
    <tradeName>PYR 50 TEST KIT</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>R30854301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838028915</udiDi>
    <basicUdiDi>8488380PYRDiskXB</basicUdiDi>
    <tradeName>PYR 100 TEST KIT</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>R30854401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838031151</udiDi>
    <basicUdiDi>8488380Pathotec7W</basicUdiDi>
    <tradeName>PATHOTEC CO (CYTOCHROME OXIDASE)</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>R38191</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:23.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838057830</udiDi>
    <basicUdiDi>8488380RapIDSpIndoleJT</basicUdiDi>
    <tradeName>RAPID INDOLE REAGENT</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>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R8309002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:23.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838057878</udiDi>
    <basicUdiDi>8488380RapIDNitrateASG</basicUdiDi>
    <tradeName>RAPID NITRATE A REAGENT</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>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R8309003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:23.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838057915</udiDi>
    <basicUdiDi>8488380RapIDNitrateBSJ</basicUdiDi>
    <tradeName>RAPID NITRATE B REAGENT</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>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R8309004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:23.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838058547</udiDi>
    <basicUdiDi>8488380RapIDInoculFLLC</basicUdiDi>
    <tradeName>RAPID INOCULATION FLUID 1ML PK/20</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>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R8325102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:23.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838058554</udiDi>
    <basicUdiDi>8488380RapIDInoculFLLC</basicUdiDi>
    <tradeName>RAPID INOCULATION FLUID 2ML PK/20</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>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R8325106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:23.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065552</udiDi>
    <basicUdiDi>8488380GrStVioletYT</basicUdiDi>
    <tradeName>GRAM CRYSTAL VIOLET 250ML</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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40052</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:23.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065569</udiDi>
    <basicUdiDi>8488380GrStVioletYT</basicUdiDi>
    <tradeName>GRAM CRYSTAL VIOLET 250ML X5</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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40053</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:23.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065576</udiDi>
    <basicUdiDi>8488380GrStDecolGC</basicUdiDi>
    <tradeName>GRAM DECOLORIZER 250ML</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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40054</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065583</udiDi>
    <basicUdiDi>8488380GrStDecolGC</basicUdiDi>
    <tradeName>GRAM DECOLORIZER 250MLX5</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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40055</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065590</udiDi>
    <basicUdiDi>8488380GrStIodineSM</basicUdiDi>
    <tradeName>GRAM IODINE 250ML</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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40056</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065606</udiDi>
    <basicUdiDi>8488380GrStIodineSM</basicUdiDi>
    <tradeName>GRAM IODINE 250MLX5</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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40057</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065613</udiDi>
    <basicUdiDi>8488380GrStSafranT3</basicUdiDi>
    <tradeName>GRAM SAFRANIN 250ML</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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40058</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065620</udiDi>
    <basicUdiDi>8488380GrStSafranT3</basicUdiDi>
    <tradeName>GRAM SAFRANIN 250ML X5</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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40059</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065651</udiDi>
    <basicUdiDi>8488380GrStVioletYT</basicUdiDi>
    <tradeName>GRAM CRYSTAL VIOLET 1GAL</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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40073</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.915Z</lastUpdated>
  </row>
</eudamedExport>