<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08595696301156</udiDi>
    <basicUdiDi>B-08595696301156</basicUdiDi>
    <tradeName>GeneProof Herpes Simplex Virus (HSV-1/2) MC PCR Kit</tradeName>
    <deviceName>GeneProof Herpes Simplex Virus (HSV-1/2) 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>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSV/MC/205</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:10.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301149</udiDi>
    <basicUdiDi>B-08595696301149</basicUdiDi>
    <tradeName>GeneProof Herpes Simplex Virus (HSV-1/2) MC PCR Kit</tradeName>
    <deviceName>GeneProof Herpes Simplex Virus (HSV-1/2) 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>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSV/MC/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:08.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301132</udiDi>
    <basicUdiDi>B-08595696301132</basicUdiDi>
    <tradeName>GeneProof Human Herpesvirus 6/7 (HHV-6/7) MC PCR Kit</tradeName>
    <deviceName>GeneProof Human Herpesvirus 6/7 (HHV-6/7) 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>W0105040524</emdnCode>
    <emdnDescription>HHV-6,7,8 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HHV/MC/205</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:06.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301125</udiDi>
    <basicUdiDi>B-08595696301125</basicUdiDi>
    <tradeName>GeneProof Human Herpesvirus 6/7 (HHV-6/7) MC PCR Kit</tradeName>
    <deviceName>GeneProof Human Herpesvirus 6/7 (HHV-6/7) 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>W0105040524</emdnCode>
    <emdnDescription>HHV-6,7,8 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HHV/MC/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:06.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300968</udiDi>
    <basicUdiDi>B-08595696300968</basicUdiDi>
    <tradeName>GeneProof Trichomonas vaginalis MC PCR Kit</tradeName>
    <deviceName>GeneProof Trichomonas 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>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:04.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300944</udiDi>
    <basicUdiDi>B-08595696300944</basicUdiDi>
    <tradeName>GeneProof Trichomonas vaginalis MC PCR Kit</tradeName>
    <deviceName>GeneProof Trichomonas 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>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:02.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300937</udiDi>
    <basicUdiDi>B-08595696300937</basicUdiDi>
    <tradeName>GeneProof Human Herpesvirus 8 (HHV-8) MC PCR Kit</tradeName>
    <deviceName>GeneProof Human Herpesvirus 8 (HHV-8) 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>W0105040524</emdnCode>
    <emdnDescription>HHV-6,7,8 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HHV8/MC/205</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:00.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300920</udiDi>
    <basicUdiDi>B-08595696300920</basicUdiDi>
    <tradeName>GeneProof Human Herpesvirus 8 (HHV-8) MC PCR Kit</tradeName>
    <deviceName>GeneProof Human Herpesvirus 8 (HHV-8) 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>W0105040524</emdnCode>
    <emdnDescription>HHV-6,7,8 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HHV8/MC/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:59.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300821</udiDi>
    <basicUdiDi>B-08595696300821</basicUdiDi>
    <tradeName>GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit</tradeName>
    <deviceName>GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HIV1D/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:58.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300760</udiDi>
    <basicUdiDi>B-08595696300760</basicUdiDi>
    <tradeName>GeneProof SARS-CoV-2 Advanced PCR Kit</tradeName>
    <deviceName>GeneProof SARS-CoV-2 Advanced 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV2A/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:55.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300807</udiDi>
    <basicUdiDi>B-08595696300807</basicUdiDi>
    <tradeName>GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit</tradeName>
    <deviceName>GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HIV1D/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:54.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300104</udiDi>
    <basicUdiDi>B-08595696300104</basicUdiDi>
    <tradeName>GeneProof SARS-CoV-2 Screening MC PCR Kit</tradeName>
    <deviceName>GeneProof SARS-CoV-2 Screening 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV2S/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:53.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300746</udiDi>
    <basicUdiDi>B-08595696300746</basicUdiDi>
    <tradeName>GeneProof SARS-CoV-2 Advanced PCR Kit</tradeName>
    <deviceName>GeneProof SARS-CoV-2 Advanced 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV2A/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:51.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300081</udiDi>
    <basicUdiDi>B-08595696300081</basicUdiDi>
    <tradeName>GeneProof SARS-CoV-2 Screening MC PCR Kit</tradeName>
    <deviceName>GeneProof SARS-CoV-2 Screening 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV2S/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:36.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300067</udiDi>
    <basicUdiDi>B-08595696300067</basicUdiDi>
    <tradeName>myCROBE Universal Internal Control</tradeName>
    <deviceName>myCROBE Universal Internal Control</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNIC/MC/180</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:34.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161959915</udiDi>
    <basicUdiDi>B-08594161959915</basicUdiDi>
    <tradeName>GeneProof Factor XIII V34L PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L 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/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:39.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161958673</udiDi>
    <basicUdiDi>B-08594161958673</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/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:36.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161958529</udiDi>
    <basicUdiDi>B-08594161958529</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/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:35.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161958512</udiDi>
    <basicUdiDi>B-08594161958512</basicUdiDi>
    <tradeName>GeneProof Factor V Leiden MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden 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>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FV/MC/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:34.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161958505</udiDi>
    <basicUdiDi>B-08594161958505</basicUdiDi>
    <tradeName>GeneProof Factor II Prothrombin MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor II Prothrombin 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>W0106010114</emdnCode>
    <emdnDescription>PROTHROMBIN MUTATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FII/MC/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:32.975Z</lastUpdated>
  </row>
</eudamedExport>