<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00848838065668</udiDi>
    <basicUdiDi>8488380GrStDecolGC</basicUdiDi>
    <tradeName>GRAM DECOLORIZER 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>R40075</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065675</udiDi>
    <basicUdiDi>8488380GrStIodineSM</basicUdiDi>
    <tradeName>GRAM IODINE 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>R40077</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065682</udiDi>
    <basicUdiDi>8488380GrStSafranT3</basicUdiDi>
    <tradeName>GRAM SAFRANIN 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>R40079</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838065699</udiDi>
    <basicUdiDi>8488380GramStainSet22</basicUdiDi>
    <tradeName>GRAM STAIN 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>STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R40080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838072710</udiDi>
    <basicUdiDi>8488380M6KitA9</basicUdiDi>
    <tradeName>MICROTEST M6 (1.5 ML) UNIVERSAL SWAB KIT PK/7</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>R12530</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838072758</udiDi>
    <basicUdiDi>8488380M6KitA9</basicUdiDi>
    <tradeName>MICROTEST M6 (1.5 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>R12557</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838074936</udiDi>
    <basicUdiDi>8488380M6KitA9</basicUdiDi>
    <tradeName>MICROTEST M6 (1.5 ML) MICRO- TIPPED 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></emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12561</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838074943</udiDi>
    <basicUdiDi>8488380M6KitA9</basicUdiDi>
    <tradeName>MICROTEST M6 (1.5 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>R12562</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838074967</udiDi>
    <basicUdiDi>8488380M4RTKitEB</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) TRADITIONAL FLOCK 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>R12565</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838074974</udiDi>
    <basicUdiDi>8488380M4RTKitEB</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) MICROTIP FLOCK 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>R12566</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838078125</udiDi>
    <basicUdiDi>8488380M6KitA9</basicUdiDi>
    <tradeName>MICROTEST M6 (3 ML) TRADITIONAL-TIPPED 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></emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12568</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838078132</udiDi>
    <basicUdiDi>8488380M6KitA9</basicUdiDi>
    <tradeName>MICROTEST M6 (3 ML) UNIVERSAL 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></emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12533</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838078149</udiDi>
    <basicUdiDi>8488380M6KitA9</basicUdiDi>
    <tradeName>MICROTEST M6 (3 ML) MICRO- TIPPED 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></emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R12569</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838078637</udiDi>
    <basicUdiDi>8488380M6KitA9</basicUdiDi>
    <tradeName>MICROTEST M6 (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>R12563</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838091322</udiDi>
    <basicUdiDi>8488380SalTweenGlassB45</basicUdiDi>
    <tradeName>SENSITITRE SALINE - TWEEN WITH GLASS BEADS</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>T3491</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:22.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384544417</udiDi>
    <basicUdiDi>8488380M4RTA3</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) WITHOUT BEADS</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>EB1367B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-18T22:31:19.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384540259</udiDi>
    <basicUdiDi>8488380M4RTKitEB</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) NPG SWAB KIT, NO BEADS 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>SK01360</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-18T22:31:17.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384530151</udiDi>
    <basicUdiDi>8488380M4RTA3</basicUdiDi>
    <tradeName>MICROTEST M4RT (3ML) WITHOUT BEADS</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>EB1348B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-18T22:31:12.875Z</lastUpdated>
  </row>
</eudamedExport>