<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08684998275354</udiDi>
    <basicUdiDi>868499827PCR96YG</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName>Aspergillus qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO96WS24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:29:15.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998275392</udiDi>
    <basicUdiDi>868499827PCR96YG</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO96WS48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:55:18.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998275439</udiDi>
    <basicUdiDi>868499827PCR96YG</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO96WS96</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:55:17.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998276191</udiDi>
    <basicUdiDi>868499827PCR96YG</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP96P25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:55:09.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998276207</udiDi>
    <basicUdiDi>868499827PCR96YG</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP96P50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:55:08.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998276214</udiDi>
    <basicUdiDi>868499827PCR96YG</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP96P100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:55:08.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Nc043ZRE4</udiDi>
    <basicUdiDi>B-697994388Nc043ZRE4</basicUdiDi>
    <tradeName>D-697994388Nc043ZRE4</tradeName>
    <deviceName>Aspergillus Nucleic Acid Detection Kit (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>Nc043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:28:07.770Z</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>08719326750996</udiDi>
    <basicUdiDi>B-08719326750996</basicUdiDi>
    <tradeName>AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit</tradeName>
    <deviceName>AsperGenius® 2.0 Resistance TR 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>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:15.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719326750989</udiDi>
    <basicUdiDi>B-08719326750989</basicUdiDi>
    <tradeName>AsperGenius® 2.0 Species Multiplex real-time PCR kit</tradeName>
    <deviceName>AsperGenius® 2.0 Species 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>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:14.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387213813</udiDi>
    <basicUdiDi>B-08684387213813</basicUdiDi>
    <tradeName>RevoDx Aspergillus qPCR Kit</tradeName>
    <deviceName>RevoDx Aspergillus 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>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202456-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:59:50.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387213806</udiDi>
    <basicUdiDi>B-08684387213806</basicUdiDi>
    <tradeName>RevoDx Aspergillus qPCR Kit</tradeName>
    <deviceName>RevoDx Aspergillus 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>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202456-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:59:49.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304447</udiDi>
    <basicUdiDi>B-08595696304447</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Aspergillus PCR Kit</tradeName>
    <deviceName>GeneProof Aspergillus PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58437</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:00:01.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161952923</udiDi>
    <basicUdiDi>B-08594161952923</basicUdiDi>
    <tradeName>GeneProof Aspergillus PCR Kit</tradeName>
    <deviceName>GeneProof Aspergillus PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASP/ISEX/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:25.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161952909</udiDi>
    <basicUdiDi>B-08594161952909</basicUdiDi>
    <tradeName>GeneProof Aspergillus PCR Kit</tradeName>
    <deviceName>GeneProof Aspergillus PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASP/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:23.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514081014</udiDi>
    <basicUdiDi>B-06970514081014</basicUdiDi>
    <tradeName>06970514081014</tradeName>
    <deviceName>Aspergillus 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>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:34.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514081007</udiDi>
    <basicUdiDi>B-06970514081007</basicUdiDi>
    <tradeName>06970514081007</tradeName>
    <deviceName>Aspergillus 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>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:33.722Z</lastUpdated>
  </row>
</eudamedExport>