<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03573026649234</udiDi>
    <basicUdiDi>357302BUDI002337TW</basicUdiDi>
    <tradeName>VITEK® 2 AST-YS10</tradeName>
    <deviceName>VITEK® 2 AST-YS10</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010403060102</emdnCode>
    <emdnDescription>SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543910</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:51:04.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251204326878</udiDi>
    <basicUdiDi>B-04251204326878</basicUdiDi>
    <tradeName>MICRONAUT-AM EUCAST AFST</tradeName>
    <deviceName>MICRONAUT-AM EUCAST AFST</deviceName>
    <manufacturerName>Bruker Daltonics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000024392</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010403060102</emdnCode>
    <emdnDescription>SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1-832-080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:41:17.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251204326861</udiDi>
    <basicUdiDi>B-04251204326861</basicUdiDi>
    <tradeName>MICRONAUT-AM Antifungal Agents MIC</tradeName>
    <deviceName>MICRONAUT-AM Antifungal Agents MIC</deviceName>
    <manufacturerName>Bruker Daltonics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000024392</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010403060102</emdnCode>
    <emdnDescription>SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1-831-040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:41:13.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577173041</udiDi>
    <basicUdiDi>697015090000070H5</basicUdiDi>
    <tradeName>YEAST ID/AST</tradeName>
    <deviceName>YEAST ID/AST</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010403060102</emdnCode>
    <emdnDescription>SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME0303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:16:10.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577173034</udiDi>
    <basicUdiDi>697015090000070H5</basicUdiDi>
    <tradeName>YEAST ID/AST</tradeName>
    <deviceName>YEAST ID/AST</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010403060102</emdnCode>
    <emdnDescription>SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME0302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:16:09.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577173027</udiDi>
    <basicUdiDi>697015090000070H5</basicUdiDi>
    <tradeName>YEAST ID/AST</tradeName>
    <deviceName>YEAST ID/AST</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010403060102</emdnCode>
    <emdnDescription>SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME0301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:16:08.118Z</lastUpdated>
  </row>
</eudamedExport>