<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08685115801012</udiDi>
    <basicUdiDi>B-08685115801012</basicUdiDi>
    <tradeName>LyoSens Bordetella pertussis qPCR Kit</tradeName>
    <deviceName>Bordetella pertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO52</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:22:24.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998277167</udiDi>
    <basicUdiDi>B-08684998277167</basicUdiDi>
    <tradeName>LyoSens  Shigella(EIEC) qPCR Kit</tradeName>
    <deviceName>Shigella (EIEC) 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>W0105011614</emdnCode>
    <emdnDescription>SHIGELLA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:52.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595037508</udiDi>
    <basicUdiDi>B-08684595037508</basicUdiDi>
    <tradeName>LyoSens™ Francisella Tularensis Detection qPCR Kit</tradeName>
    <deviceName>LyoSens™ Francisella Tularensis 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO91</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:16:59.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215602</udiDi>
    <basicUdiDi>B-08684387215602</basicUdiDi>
    <tradeName>RevoDx Leptospira spp qPCR Kit</tradeName>
    <deviceName>RevoDx Leptospira spp 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>W0105011604</emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202525-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:41.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215596</udiDi>
    <basicUdiDi>B-08684387215596</basicUdiDi>
    <tradeName>RevoDx Leptospira spp qPCR Kit</tradeName>
    <deviceName>RevoDx Leptospira spp 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>W0105011604</emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202525-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:40.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387213462</udiDi>
    <basicUdiDi>B-08684387213462</basicUdiDi>
    <tradeName>RevoDx Neisseria Meningitidis qPCR Kit</tradeName>
    <deviceName>RevoDx Neisseria Meningitidis 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>W0105011611</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202235-500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:57:15.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212946</udiDi>
    <basicUdiDi>B-08684387212946</basicUdiDi>
    <tradeName>RevoDx Yersinia Enterocolitica qPCR Kit</tradeName>
    <deviceName>RevoDx Yersinia Enterocolitica 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>W0105011606</emdnCode>
    <emdnDescription>YERSINIA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202442-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:55:20.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212939</udiDi>
    <basicUdiDi>B-08684387212939</basicUdiDi>
    <tradeName>RevoDx Yersinia Enterocolitica qPCR Kit</tradeName>
    <deviceName>RevoDx Yersinia Enterocolitica 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>W0105011606</emdnCode>
    <emdnDescription>YERSINIA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202442-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:55:15.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212687</udiDi>
    <basicUdiDi>B-08684387212687</basicUdiDi>
    <tradeName>RevoDx Haemophilus influenzae qPCR Kit</tradeName>
    <deviceName>RevoDx Haemophilus influenzae 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>W0105011610</emdnCode>
    <emdnDescription>HAEMOPHILUS INFLUENZAE - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202252-500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:34.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212670</udiDi>
    <basicUdiDi>B-08684387212670</basicUdiDi>
    <tradeName>RevoDx Bordetella pertussis/parapertussis qPCR Kit</tradeName>
    <deviceName>RevoDx Bordetella pertussis/parapertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202331-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:19.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212663</udiDi>
    <basicUdiDi>B-08684387212663</basicUdiDi>
    <tradeName>RevoDx Bordetella pertussis/parapertussis qPCR Kit</tradeName>
    <deviceName>RevoDx Bordetella pertussis/parapertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202331-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:18.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212656</udiDi>
    <basicUdiDi>B-08684387212656</basicUdiDi>
    <tradeName>RevoDx Bordetella pertussis qPCR Kit</tradeName>
    <deviceName>RevoDx Bordetella pertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202330-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:18.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212649</udiDi>
    <basicUdiDi>B-08684387212649</basicUdiDi>
    <tradeName>RevoDx Bordetella pertussis qPCR Kit</tradeName>
    <deviceName>RevoDx Bordetella pertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202330-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:17.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548259400</udiDi>
    <basicUdiDi>B-08683548259400</basicUdiDi>
    <tradeName>LyoSens Shigella/Enteroinvasive E. coli (EIEC) Detection qPCR Kit</tradeName>
    <deviceName>Shigella/Enteroinvasive E. coli (EIEC) 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>W0105011614</emdnCode>
    <emdnDescription>SHIGELLA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:20:51.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548259394</udiDi>
    <basicUdiDi>B-08683548259394</basicUdiDi>
    <tradeName>LyoSens Yersinia enterocolitica Detection qPCR Kit</tradeName>
    <deviceName>Yersinia enterocolitica 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>W0105011606</emdnCode>
    <emdnDescription>YERSINIA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:20:47.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548258809</udiDi>
    <basicUdiDi>B-08683548258809</basicUdiDi>
    <tradeName>LyoSens Aeromonas + Yersinia enterocolitica Detection qPCR Kit</tradeName>
    <deviceName>Aeromonas + Yersinia enterocolitica 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:20:01.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548258762</udiDi>
    <basicUdiDi>B-08683548258762</basicUdiDi>
    <tradeName>LyoSens Entamoeba dispar Detection qPCR Kit</tradeName>
    <deviceName>Entamoeba dispar 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:19:55.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548258618</udiDi>
    <basicUdiDi>B-08683548258618</basicUdiDi>
    <tradeName>LyoSens Shigella/Enteroinvasive E. coli (EIEC) Detection qPCR Kit</tradeName>
    <deviceName>Shigella/Enteroinvasive E. coli (EIEC) 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>W0105011614</emdnCode>
    <emdnDescription>SHIGELLA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:19:32.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548258601</udiDi>
    <basicUdiDi>B-08683548258601</basicUdiDi>
    <tradeName>LyoSens Yersinia enterocolitica Detection qPCR Kit</tradeName>
    <deviceName>Yersinia enterocolitica 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>W0105011606</emdnCode>
    <emdnDescription>YERSINIA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:19:29.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548257789</udiDi>
    <basicUdiDi>B-08683548257789</basicUdiDi>
    <tradeName>ChainFor Bordetella pertussis Detection qPCR Kit</tradeName>
    <deviceName>Bordetella pertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:17:00.083Z</lastUpdated>
  </row>
</eudamedExport>