<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08595696302696</udiDi>
    <basicUdiDi>B-08595696302696</basicUdiDi>
    <tradeName>GeneProof Factor XIII V34L MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L MC 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXIII/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:55.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302399</udiDi>
    <basicUdiDi>B-08595696302399</basicUdiDi>
    <tradeName>GeneProof Gardnerella vaginalis MC PCR Kit</tradeName>
    <deviceName>GeneProof Gardnerella vaginalis MC 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GV/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:53.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302443</udiDi>
    <basicUdiDi>B-08595696302443</basicUdiDi>
    <tradeName>GeneProof Ureaplasma urealyticum MC PCR Kit</tradeName>
    <deviceName>GeneProof Ureaplasma urealyticum MC 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UU/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:52.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302382</udiDi>
    <basicUdiDi>B-08595696302382</basicUdiDi>
    <tradeName>GeneProof Gardnerella vaginalis MC PCR Kit</tradeName>
    <deviceName>GeneProof Gardnerella vaginalis MC 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GV/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:38.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302368</udiDi>
    <basicUdiDi>B-08595696302368</basicUdiDi>
    <tradeName>GeneProof Ureaplasma parvum MC PCR Kit</tradeName>
    <deviceName>GeneProof Ureaplasma parvum MC 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:36.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302351</udiDi>
    <basicUdiDi>B-08595696302351</basicUdiDi>
    <tradeName>GeneProof Ureaplasma parvum MC PCR Kit</tradeName>
    <deviceName>GeneProof Ureaplasma parvum MC 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:34.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302337</udiDi>
    <basicUdiDi>B-08595696302337</basicUdiDi>
    <tradeName>GeneProof Ureaplasma urealyticum MC PCR Kit</tradeName>
    <deviceName>GeneProof Ureaplasma urealyticum MC 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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UU/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:32.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302016</udiDi>
    <basicUdiDi>B-08595696302016</basicUdiDi>
    <tradeName>GeneProof Mycoplasma hominis MC PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma hominis MC 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>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:31.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302009</udiDi>
    <basicUdiDi>B-08595696302009</basicUdiDi>
    <tradeName>GeneProof Mycoplasma hominis MC PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma hominis MC 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>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:30.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301989</udiDi>
    <basicUdiDi>B-08595696301989</basicUdiDi>
    <tradeName>GeneProof Mycoplasma genitalium MC PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma genitalium MC 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>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:27.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301972</udiDi>
    <basicUdiDi>B-08595696301972</basicUdiDi>
    <tradeName>GeneProof Mycoplasma genitalium MC PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma genitalium MC 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>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:26.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301927</udiDi>
    <basicUdiDi>B-08595696301927</basicUdiDi>
    <tradeName>GeneProof Neisseria gonorrhoeae MC PCR Kit</tradeName>
    <deviceName>GeneProof Neisseria gonorrhoeae MC 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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NG/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:25.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301903</udiDi>
    <basicUdiDi>B-08595696301903</basicUdiDi>
    <tradeName>GeneProof Neisseria gonorrhoeae MC PCR Kit</tradeName>
    <deviceName>GeneProof Neisseria gonorrhoeae MC 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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NG/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:23.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301224</udiDi>
    <basicUdiDi>B-08595696301224</basicUdiDi>
    <tradeName>GeneProof Varicella-Zoster Virus (VZV) MC PCR Kit</tradeName>
    <deviceName>GeneProof Varicella-Zoster Virus (VZV) MC 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>W0105040904</emdnCode>
    <emdnDescription>VARICELLA ZOSTER  - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VZV/MC/205</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:21.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301217</udiDi>
    <basicUdiDi>B-08595696301217</basicUdiDi>
    <tradeName>GeneProof Varicella-Zoster Virus (VZV) MC PCR Kit</tradeName>
    <deviceName>GeneProof Varicella-Zoster Virus (VZV) MC 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>W0105040904</emdnCode>
    <emdnDescription>VARICELLA ZOSTER  - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VZV/MC/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:19.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301200</udiDi>
    <basicUdiDi>B-08595696301200</basicUdiDi>
    <tradeName>GeneProof JC Virus (JCV) MC PCR Kit</tradeName>
    <deviceName>GeneProof JC Virus (JCV) MC 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>W0105040523</emdnCode>
    <emdnDescription>JC VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JCV/MC/205</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:18.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301194</udiDi>
    <basicUdiDi>B-08595696301194</basicUdiDi>
    <tradeName>GeneProof JC Virus (JCV) MC PCR Kit</tradeName>
    <deviceName>GeneProof JC Virus (JCV) MC 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>W0105040523</emdnCode>
    <emdnDescription>JC VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JCV/MC/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:17.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301187</udiDi>
    <basicUdiDi>B-08595696301187</basicUdiDi>
    <tradeName>GeneProof BK Virus (BKV) MC PCR Kit</tradeName>
    <deviceName>GeneProof BK Virus (BKV) MC 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>W0105040522</emdnCode>
    <emdnDescription>BK VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BKV/MC/205</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:14.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301170</udiDi>
    <basicUdiDi>B-08595696301170</basicUdiDi>
    <tradeName>GeneProof BK Virus (BKV) MC PCR Kit</tradeName>
    <deviceName>GeneProof BK Virus (BKV) MC 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>W0105040522</emdnCode>
    <emdnDescription>BK VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BKV/MC/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:13.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301163</udiDi>
    <basicUdiDi>B-08595696301163</basicUdiDi>
    <tradeName>GeneProof Epstein-Barr Virus (EBV) MC PCR Kit</tradeName>
    <deviceName>GeneProof Epstein-Barr Virus (EBV) MC 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>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBV/MC/205</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:12.434Z</lastUpdated>
  </row>
</eudamedExport>