<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04170000059325</udiDi>
    <basicUdiDi>417000005932S-LGA-1006V</basicUdiDi>
    <tradeName>LiveGene Analysis</tradeName>
    <deviceName>LiveGene Analysis</deviceName>
    <manufacturerName>Seqstant GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035679</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LGA-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:45:36.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>111917794233</udiDi>
    <basicUdiDi>PP12579SWIFTX.DNA29</basicUdiDi>
    <tradeName>111917794233</tradeName>
    <deviceName>SwiftX DNA</deviceName>
    <manufacturerName>Xpedite Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020021</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SXD-25-IVD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:38:20.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICRG-R4028A</udiDi>
    <basicUdiDi>B-ICRG-R4028A</basicUdiDi>
    <tradeName>Cryptococcus Antigen Rapid Test Cassette</tradeName>
    <deviceName>Cryptococcus Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:13.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICA-R5026W</udiDi>
    <basicUdiDi>B-ICA-R5026W</basicUdiDi>
    <tradeName>Candida albicans Rapid Test Cassette</tradeName>
    <deviceName>Candida albicans Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:04:43.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD135XH</udiDi>
    <basicUdiDi>B-GKPD135XH</basicUdiDi>
    <tradeName>Candida albicans Ag Rapid Test Kit</tradeName>
    <deviceName>Candida albicans Ag Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD135</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:09.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCr(Ag)-402aRU</udiDi>
    <basicUdiDi>B-GCCr(Ag)-402aRU</basicUdiDi>
    <tradeName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</tradeName>
    <deviceName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCr(Ag)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:31.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCr(Ag)-402aHGDP</udiDi>
    <basicUdiDi>B-GCCr(Ag)-402aHGDP</basicUdiDi>
    <tradeName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</tradeName>
    <deviceName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCr(Ag)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:30.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCA-502aHGAL</udiDi>
    <basicUdiDi>B-GCCA-502aHGAL</basicUdiDi>
    <tradeName>Candida albicans Antigen Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Candida albicans Antigen Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCA-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:06.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCA-502aQC</udiDi>
    <basicUdiDi>B-GCCA-502aQC</basicUdiDi>
    <tradeName>Candida albicans Antigen Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Candida albicans Antigen Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCA-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:04.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M708021FK</udiDi>
    <basicUdiDi>B-G2M708021FK</basicUdiDi>
    <tradeName>C. Albicans-Q Real- Time PCR Kit</tradeName>
    <deviceName>C. Albicans-Q Real- Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M708021, G2M708021R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:44:17.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277935712T</udiDi>
    <basicUdiDi>B-37700277935712T</basicUdiDi>
    <tradeName>ASPERGILLUS WB IgG</tradeName>
    <deviceName>ASPERGILLUS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASP-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:27.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277935642W</udiDi>
    <basicUdiDi>B-37700277935642W</basicUdiDi>
    <tradeName>ASPERGILLUS WB IgG</tradeName>
    <deviceName>ASPERGILLUS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASP-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:26.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277935572Z</udiDi>
    <basicUdiDi>B-37700277935572Z</basicUdiDi>
    <tradeName>ASPERGILLUS WB IgG</tradeName>
    <deviceName>ASPERGILLUS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASP-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:25.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277933732M</udiDi>
    <basicUdiDi>B-37700277933732M</basicUdiDi>
    <tradeName>ASPERGILLUS ICT IgG-IgM</tradeName>
    <deviceName>ASPERGILLUS ICT IgG-IgM</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASPG Ab ICT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:56:40.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277933662Q</udiDi>
    <basicUdiDi>B-37700277933662Q</basicUdiDi>
    <tradeName>ASPERGILLUS ICT IgG-IgM</tradeName>
    <deviceName>ASPERGILLUS ICT IgG-IgM</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASPG Ab ICT20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:56:40.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>38594036047021</udiDi>
    <basicUdiDi>B-38594036047021</basicUdiDi>
    <tradeName>MONO -VIDITEST anti-Aspergillus fumigatus IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-702-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:55:04.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>38594036047014</udiDi>
    <basicUdiDi>B-38594036047014</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Aspergillus fumigatus IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-701-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:55:04.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>38594036047007</udiDi>
    <basicUdiDi>B-38594036047007</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Aspergillus fumigatus IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-700-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:57.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036045143</udiDi>
    <basicUdiDi>B-28594036045143</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Aspergillus fumigatus IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-514</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:22:17.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036045136</udiDi>
    <basicUdiDi>B-28594036045136</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Aspergillus fumigatus IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-513</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:22:16.848Z</lastUpdated>
  </row>
</eudamedExport>