<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03573026137892</udiDi>
    <basicUdiDi>357302BUDI000254TB</basicUdiDi>
    <tradeName>Sabouraud Gentamicin Chloramphenicol 2 agar</tradeName>
    <deviceName>Sabouraud Gentamicin Chloramphenicol 2 agar</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030301</emdnCode>
    <emdnDescription>TUBES FOR YEASTS AND FUNGI</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42031</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:50:33.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026092405</udiDi>
    <basicUdiDi>357302BUDI000497U7</basicUdiDi>
    <tradeName>Mycoline (MYCOLINE)</tradeName>
    <deviceName>Mycoline (MYCOLINE)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030405</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - MANUAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>56525</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:49:59.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026073664</udiDi>
    <basicUdiDi>357302BUDI000473TR</basicUdiDi>
    <tradeName>Sabouraud liquid broth</tradeName>
    <deviceName>Sabouraud liquid broth</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030301</emdnCode>
    <emdnDescription>TUBES FOR YEASTS AND FUNGI</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42108</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:49:27.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026073527</udiDi>
    <basicUdiDi>357302BUDI000256TF</basicUdiDi>
    <tradeName>Sabouraud Chloramphenicol Actidione Agar</tradeName>
    <deviceName>Sabouraud Chloramphenicol Actidione Agar</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030301</emdnCode>
    <emdnDescription>TUBES FOR YEASTS AND FUNGI</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42094</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:49:01.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026066383</udiDi>
    <basicUdiDi>357302BUDI000252T7</basicUdiDi>
    <tradeName>ID 32 C</tradeName>
    <deviceName>ID 32 C</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030405</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - MANUAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:48.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026048082</udiDi>
    <basicUdiDi>357302BUDI000215SZ</basicUdiDi>
    <tradeName>API® 20 C AUX</tradeName>
    <deviceName>API® 20 C AUX</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030405</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - MANUAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20210</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:47:40.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026035693</udiDi>
    <basicUdiDi>357302BUDI000207T2</basicUdiDi>
    <tradeName>API® Candida</tradeName>
    <deviceName>API® Candida</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030405</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - MANUAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10500</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:47:34.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026529697</udiDi>
    <basicUdiDi>357302BUDI000218T7</basicUdiDi>
    <tradeName>VITEK® 2 YST</tradeName>
    <deviceName>VITEK® 2 YST</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>W0104030403</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308128</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:07.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7003AN</udiDi>
    <basicUdiDi>B-7003AN</basicUdiDi>
    <tradeName>MIC NEF</tradeName>
    <deviceName>MIC NEF</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010403060101</emdnCode>
    <emdnDescription>SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - MANUAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7003</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:41:38.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026600860</udiDi>
    <basicUdiDi>357302BUDI000128T5</basicUdiDi>
    <tradeName>Sabouraud Gentamicin Chloramphenicol 2 Agar</tradeName>
    <deviceName>Sabouraud Gentamicin Chloramphenicol 2 Agar</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030201</emdnCode>
    <emdnDescription>PPM FOR YEASTS AND FUNGI</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>542282</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:53.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026600525</udiDi>
    <basicUdiDi>357302BUDI000261T8</basicUdiDi>
    <tradeName>Dermatophyte Agar</tradeName>
    <deviceName>Dermatophyte Agar</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030201</emdnCode>
    <emdnDescription>PPM FOR YEASTS AND FUNGI</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>542248</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:39.532Z</lastUpdated>
  </row>
  <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>08594224840051</udiDi>
    <basicUdiDi>08594224840051SU</basicUdiDi>
    <tradeName>S</tradeName>
    <deviceName>S</deviceName>
    <manufacturerName>Zdravotní ústav se sídlem v Ostravě</manufacturerName>
    <manufacturerSrn>CZ-MF-000046342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030299</emdnCode>
    <emdnDescription>PREPARED MEDIA IN PLATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>006</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:56:18.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904483166</udiDi>
    <basicUdiDi>038290JHJJQPLUAD</basicUdiDi>
    <tradeName>Phoenix</tradeName>
    <deviceName>BD Phoenix™ YEAST ID</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030403</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>448316</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:58.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS01289Q8</udiDi>
    <basicUdiDi>B-MS01289Q8</basicUdiDi>
    <tradeName>YEASTS WELL D-ONE</tradeName>
    <deviceName>YEASTS WELL D-ONE</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104030405</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - MANUAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS01289</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:13:36.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044006388</udiDi>
    <basicUdiDi>B-09343044006388</basicUdiDi>
    <tradeName>RIDA®Plex Dermatophytes and other Fungi 12 well Step 1</tradeName>
    <deviceName>RIDA®Plex Dermatophytes and other Fungi 12 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104030404</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84115S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:44:18.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044006371</udiDi>
    <basicUdiDi>B-09343044006371</basicUdiDi>
    <tradeName>RIDA®Plex Dermatophytes and other Fungi 12 well Step 2</tradeName>
    <deviceName>RIDA®Plex Dermatophytes and other Fungi 12 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104030404</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84115P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:44:17.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044003349</udiDi>
    <basicUdiDi>B-09343044003349</basicUdiDi>
    <tradeName>Dermatophytes and other Fungi 12-well</tradeName>
    <deviceName>Step 1 tubes for Dermatophytes and other Fungi 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104030404</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84115S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:01.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044003332</udiDi>
    <basicUdiDi>B-09343044003332</basicUdiDi>
    <tradeName>Dermatophytes and other Fungi 12-well</tradeName>
    <deviceName>Step 2 Plates for Dermatophytes and other Fungi 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104030404</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84115P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:00.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548256997</udiDi>
    <basicUdiDi>B-08683548256997</basicUdiDi>
    <tradeName>ChainFor Candida Auris Detection qPCR Kit</tradeName>
    <deviceName>Candida Auris Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104030404</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP97</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:52.570Z</lastUpdated>
  </row>
</eudamedExport>