<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>00848838022470</udiDi>
    <basicUdiDi>8488380BctCrdNeisseriaBV</basicUdiDi>
    <tradeName>BACTICARD NEISSERIA</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>R21110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022494</udiDi>
    <basicUdiDi>8488380BactiCardStrep3A</basicUdiDi>
    <tradeName>BACTICARD STREP</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>R21112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022593</udiDi>
    <basicUdiDi>8488380CatarrhalisDiskQM</basicUdiDi>
    <tradeName>CATARRHALIS TEST 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>R21121</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022746</udiDi>
    <basicUdiDi>8488380MicrodaseDiskAG</basicUdiDi>
    <tradeName>MICRODASE 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>R21132</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023088</udiDi>
    <basicUdiDi>8488380NitrocefinDisk47</basicUdiDi>
    <tradeName>NITROCEFIN 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>R211667</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023743</udiDi>
    <basicUdiDi>8488380BDrpAcridOrangeGM</basicUdiDi>
    <tradeName>BACTIDROP ACRIDINE ORANGE</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>R21502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023750</udiDi>
    <basicUdiDi>8488380BDrpCalcoFWhite5G</basicUdiDi>
    <tradeName>BACTIDROP CALCOFLUOR WHITE</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>R21507</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023767</udiDi>
    <basicUdiDi>8488380BDrpDesoxychocZ6</basicUdiDi>
    <tradeName>BACTIDROP DESOXYCHOLATE (10%)</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>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21508</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023774</udiDi>
    <basicUdiDi>8488380BDrpDOCIodineB7</basicUdiDi>
    <tradeName>BACTIDROP DOBELL and O'CONNOR IODINE</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>R21510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023781</udiDi>
    <basicUdiDi>8488380BDrpFeChlorideXU</basicUdiDi>
    <tradeName>BACTIDROP FERRIC CHLORIDE (10%)</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>R21514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023798</udiDi>
    <basicUdiDi>8488380BDrpIndiaInkRV</basicUdiDi>
    <tradeName>BACTIDROP INDIA INK</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>R21518</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023811</udiDi>
    <basicUdiDi>8488380BDrpIndoleKovP2</basicUdiDi>
    <tradeName>BACTIDROP INDOLE (KOVACS)</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>R21522</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023828</udiDi>
    <basicUdiDi>8488380BDrpKOHQG</basicUdiDi>
    <tradeName>BACTIDROP KOH (10%)</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>R21524</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.190Z</lastUpdated>
  </row>
</eudamedExport>