<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697994388Fa044WM8L</udiDi>
    <basicUdiDi>B-697994388Fa044WM8L</basicUdiDi>
    <tradeName>D-697994388Fa044WM8L</tradeName>
    <deviceName>Cryptococcus Nucleic Acid Detection Kit (Fluorescence, CSF)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060403</emdnCode>
    <emdnDescription>CRYPTOCOCCUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:22:57.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Fa043WK8B</udiDi>
    <basicUdiDi>B-697994388Fa043WK8B</basicUdiDi>
    <tradeName>D-697994388Fa043WK8B</tradeName>
    <deviceName>Aspergillus Nucleic Acid Detection Kit (Fluorescence, Sputum/BALF)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:22:55.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICANM0060DS0O</udiDi>
    <basicUdiDi>B-+ENTICANM0060DS0O</basicUdiDi>
    <tradeName>+ENTICANM0060DS0O</tradeName>
    <deviceName>NovaLisa® Candida albicans IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CANM0060DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:09:49.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICANM00600Q</udiDi>
    <basicUdiDi>B-+ENTICANM00600Q</basicUdiDi>
    <tradeName>+ENTICANM00600Q</tradeName>
    <deviceName>NovaLisa® Candida albicans IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CANM0060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:09:45.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICANG0060DS0I</udiDi>
    <basicUdiDi>B-+ENTICANG0060DS0I</basicUdiDi>
    <tradeName>+ENTICANG0060DS0I</tradeName>
    <deviceName>NovaLisa® Candida albicans IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CANG0060DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:09:44.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICANG00600K</udiDi>
    <basicUdiDi>B-+ENTICANG00600K</basicUdiDi>
    <tradeName>+ENTICANG00600K</tradeName>
    <deviceName>NovaLisa® Candida albicans IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CANG0060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:09:43.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICANA0060DS0C</udiDi>
    <basicUdiDi>B-+ENTICANA0060DS0C</basicUdiDi>
    <tradeName>+ENTICANA0060DS0C</tradeName>
    <deviceName>NovaLisa® Candida albicans IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CANA0060DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:09:42.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICANA00600E</udiDi>
    <basicUdiDi>B-+ENTICANA00600E</basicUdiDi>
    <tradeName>+ENTICANA00600E</tradeName>
    <deviceName>NovaLisa® Candida albicans IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CANA0060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:09:38.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIASPM0680DS07</udiDi>
    <basicUdiDi>B-+ENTIASPM0680DS07</basicUdiDi>
    <tradeName>+ENTIASPM0680DS07</tradeName>
    <deviceName>NovaLisa® Aspergillus fumigatus IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASPM0680DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:08:52.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIASPM068009</udiDi>
    <basicUdiDi>B-+ENTIASPM068009</basicUdiDi>
    <tradeName>+ENTIASPM068009</tradeName>
    <deviceName>NovaLisa® Aspergillus fumigatus IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASPM0680</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:08:51.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIASPG0680DS01</udiDi>
    <basicUdiDi>B-+ENTIASPG0680DS01</basicUdiDi>
    <tradeName>+ENTIASPG0680DS01</tradeName>
    <deviceName>NovaLisa® Aspergillus fumigatus IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASPG0680DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:08:51.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIASPG068003</udiDi>
    <basicUdiDi>B-+ENTIASPG068003</basicUdiDi>
    <tradeName>+ENTIASPG068003</tradeName>
    <deviceName>NovaLisa® Aspergillus fumigatus IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASPG0680</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:08:48.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301136190K</udiDi>
    <basicUdiDi>B-+ENTI301136190K</basicUdiDi>
    <tradeName>+ENTI301136190K</tradeName>
    <deviceName>Candida albicans IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113619</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:48.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301136180J</udiDi>
    <basicUdiDi>B-+ENTI301136180J</basicUdiDi>
    <tradeName>+ENTI301136180J</tradeName>
    <deviceName>Candida albicans IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113618</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:47.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301136170I</udiDi>
    <basicUdiDi>B-+ENTI301136170I</basicUdiDi>
    <tradeName>+ENTI301136170I</tradeName>
    <deviceName>Candida albicans IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113617</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:43.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301134710G</udiDi>
    <basicUdiDi>B-+ENTI301134710G</basicUdiDi>
    <tradeName>+ENTI301134710G</tradeName>
    <deviceName>Aspergillus fumigatus IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113471</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:12.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301134680M</udiDi>
    <basicUdiDi>B-+ENTI301134680M</basicUdiDi>
    <tradeName>+ENTI301134680M</tradeName>
    <deviceName>Aspergillus fumigatus IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113468</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:11.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440258261</udiDi>
    <basicUdiDi>84354402_MDXRESIST_CAUL3</basicUdiDi>
    <tradeName>VIASURE Candida auris Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Candida auris Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060404</emdnCode>
    <emdnDescription>CANDIDA AURIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CAU101L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:50.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891488598</udiDi>
    <basicUdiDi>803389148CAU739M</basicUdiDi>
    <tradeName>Candida auris ELITe MGB® Kit</tradeName>
    <deviceName>Candida auris ELITe MGB® Kit</deviceName>
    <manufacturerName>ElitechGroup S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005919</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060404</emdnCode>
    <emdnDescription>CANDIDA AURIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTS203ING</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:48:06.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481163796</udiDi>
    <basicUdiDi>498748114987481163802ZB</basicUdiDi>
    <tradeName>β-Glucan Test R2: LAL Reagent</tradeName>
    <deviceName>β-Glucan Test R1: Pretreatment Solution, β-Glucan Test R2: LAL Reagent, LAL Control</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060304</emdnCode>
    <emdnDescription>BETA-D-GLUCAN (PAN-FUNGAL MARKERS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997-04101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:42:55.252Z</lastUpdated>
  </row>
</eudamedExport>