<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>08719327498019</udiDi>
    <basicUdiDi>B-08719327498019</basicUdiDi>
    <tradeName>DermaGenius® 3.0 Complete Multiplex real-time PCR kit</tradeName>
    <deviceName>DermaGenius® 3.0 Complete Multiplex real-time PCR kit</deviceName>
    <manufacturerName>PathoNostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:44.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595033791</udiDi>
    <basicUdiDi>B-08684595033791</basicUdiDi>
    <tradeName>ChainFor Candida Albicans Detection qPCR Kit</tradeName>
    <deviceName>Candida Albicans 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>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:15:52.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387211994</udiDi>
    <basicUdiDi>B-08684387211994</basicUdiDi>
    <tradeName>RevoDx Candida albicans qPCR Kit</tradeName>
    <deviceName>RevoDx Candida albicans qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202215-500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:09.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387211987</udiDi>
    <basicUdiDi>B-08684387211987</basicUdiDi>
    <tradeName>RevoDx Candida albicans qPCR Kit</tradeName>
    <deviceName>RevoDx Candida albicans qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202215-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:04.984Z</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>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>06970514081076</udiDi>
    <basicUdiDi>B-06970514081076</basicUdiDi>
    <tradeName>Candida auris Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Candida auris 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>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCUPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:52.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514081069</udiDi>
    <basicUdiDi>B-06970514081069</basicUdiDi>
    <tradeName>Candida auris Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Candida auris 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>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCUPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:48.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514081052</udiDi>
    <basicUdiDi>B-06970514081052</basicUdiDi>
    <tradeName>06970514081052</tradeName>
    <deviceName>Candida 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>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCAPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:45.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514081045</udiDi>
    <basicUdiDi>B-06970514081045</basicUdiDi>
    <tradeName>06970514081045</tradeName>
    <deviceName>Candida 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>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCAPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:44.505Z</lastUpdated>
  </row>
</eudamedExport>