<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08435440260523</udiDi>
    <basicUdiDi>84354402_MDXRESIST_CAUL3</basicUdiDi>
    <tradeName>VIASURE Candida auris Real Time PCR Detection Kit</tradeName>
    <deviceName></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-CAU106HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:54:10.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260530</udiDi>
    <basicUdiDi>84354402_MDXRESIST_CAUL3</basicUdiDi>
    <tradeName>VIASURE Candida auris Real Time PCR Detection Kit</tradeName>
    <deviceName></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-CAU112LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:54:10.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260547</udiDi>
    <basicUdiDi>84354402_MDXRESIST_CAUL3</basicUdiDi>
    <tradeName>VIASURE Candida auris Real Time PCR Detection Kit</tradeName>
    <deviceName></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-CAU112HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:54:09.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260554</udiDi>
    <basicUdiDi>84354402_MDXRESIST_CAUL3</basicUdiDi>
    <tradeName>VIASURE Candida auris Real Time PCR Detection Kit</tradeName>
    <deviceName></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-CAU113LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:54:08.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260561</udiDi>
    <basicUdiDi>84354402_MDXRESIST_CAUL3</basicUdiDi>
    <tradeName>VIASURE Candida auris Real Time PCR Detection Kit</tradeName>
    <deviceName></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-CAU113HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:54:08.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260578</udiDi>
    <basicUdiDi>84354402_MDXRESIST_CAUL3</basicUdiDi>
    <tradeName>VIASURE Candida auris Real Time PCR Detection Kit</tradeName>
    <deviceName></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-CAU196TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:54:07.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042229169</udiDi>
    <basicUdiDi>B-06971042229169</basicUdiDi>
    <tradeName>Pneumocystis jirovecii Real Time PCR Kit</tradeName>
    <deviceName>Pneumocystis jirovecii Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QD-0082-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:37.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042228995</udiDi>
    <basicUdiDi>B-06971042228995</basicUdiDi>
    <tradeName>Fungus Real Time PCR Kit</tradeName>
    <deviceName>Fungus Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-0330-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:08.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042228988</udiDi>
    <basicUdiDi>B-06971042228988</basicUdiDi>
    <tradeName>Candida Albicans Real Time PCR Kit</tradeName>
    <deviceName>Candida Albicans Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-0329-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:06.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042225161</udiDi>
    <basicUdiDi>B-06971042225161</basicUdiDi>
    <tradeName>Cryptococcus Neoformans Real Time PCR Kit</tradeName>
    <deviceName>Cryptococcus Neoformans Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-0328-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:59.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719326750934</udiDi>
    <basicUdiDi>87193267509PN-401EQ</basicUdiDi>
    <tradeName>DermaGenius® 2.0 Complete Multiplex real-time PCR kit</tradeName>
    <deviceName>DermaGenius® 2.0 Complete Multiplex real-time PCR kit</deviceName>
    <manufacturerName>PathoNostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:35:16.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436610290180</udiDi>
    <basicUdiDi>843661029RTPCR027018Y</basicUdiDi>
    <tradeName>PNEUMOCYSTIS JIROVECII REALTIME PCR KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTPCR027-LP</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:57:48.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770041419099</udiDi>
    <basicUdiDi>377004141960318CK</basicUdiDi>
    <tradeName>03770041419099</tradeName>
    <deviceName>Long Life MycoGENIE® Pneumocystis jirovecii Real Time PCR</deviceName>
    <manufacturerName>ADEMTECH</manufacturerName>
    <manufacturerSrn>FR-MF-000048678</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060405</emdnCode>
    <emdnDescription>PNEUMOCYSTIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60318</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:16:30.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770041419044</udiDi>
    <basicUdiDi>377004141960307CE</basicUdiDi>
    <tradeName>03770041419044</tradeName>
    <deviceName>MycoGENIE® Pneumocystis jirovecii Real Time PCR</deviceName>
    <manufacturerName>ADEMTECH</manufacturerName>
    <manufacturerSrn>FR-MF-000048678</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060405</emdnCode>
    <emdnDescription>PNEUMOCYSTIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60307</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:16:28.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970895475655</udiDi>
    <basicUdiDi>B-06970895475655</basicUdiDi>
    <tradeName>06970895475655</tradeName>
    <deviceName>Candida auris and Antibiotic-Resistant Strain Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060404</emdnCode>
    <emdnDescription>CANDIDA AURIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B70201T2048</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:38.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970895475648</udiDi>
    <basicUdiDi>B-06970895475648</basicUdiDi>
    <tradeName>06970895475648</tradeName>
    <deviceName>Candida Auris Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060404</emdnCode>
    <emdnDescription>CANDIDA AURIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B701T050B0C1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:37.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514081137</udiDi>
    <basicUdiDi>B-06970514081137</basicUdiDi>
    <tradeName>Cryptococcus Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Cryptococcus Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060403</emdnCode>
    <emdnDescription>CRYPTOCOCCUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:08:03.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514081120</udiDi>
    <basicUdiDi>B-06970514081120</basicUdiDi>
    <tradeName>Cryptococcus Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Cryptococcus Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060403</emdnCode>
    <emdnDescription>CRYPTOCOCCUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:58.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514081113</udiDi>
    <basicUdiDi>B-06970514081113</basicUdiDi>
    <tradeName>Talaromyces marneffei Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Talaromyces marneffei Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTMPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:56.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514081106</udiDi>
    <basicUdiDi>B-06970514081106</basicUdiDi>
    <tradeName>Talaromyces marneffei Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Talaromyces marneffei Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTMPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:55.291Z</lastUpdated>
  </row>
</eudamedExport>