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<eudamedExport entity="devices">
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    <udiDi>08595696304287</udiDi>
    <basicUdiDi>B-08595696304287</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Factor V Leiden PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden 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>A58421</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:27.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304270</udiDi>
    <basicUdiDi>B-08595696304270</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Factor II Prothrombin PCR Kit</tradeName>
    <deviceName>GeneProof Factor II Prothrombin 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>A58420</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:25.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304133</udiDi>
    <basicUdiDi>B-08595696304133</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Adenovirus PCR Kit</tradeName>
    <deviceName>GeneProof Adenovirus 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>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58213</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:23.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304126</udiDi>
    <basicUdiDi>B-08595696304126</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Bordetella pertussis/parapertussis PCR Kit</tradeName>
    <deviceName>GeneProof Bordetella pertussis/parapertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58208</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:23.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304119</udiDi>
    <basicUdiDi>B-08595696304119</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Enterovirus PCR Kit</tradeName>
    <deviceName>GeneProof Enterovirus 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>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58211</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:21.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304089</udiDi>
    <basicUdiDi>B-08595696304089</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Mycoplasma pneumoniae PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma pneumoniae 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>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58210</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:19.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304072</udiDi>
    <basicUdiDi>B-08595696304072</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Mycobacterium tuberculosis PCR Kit</tradeName>
    <deviceName>GeneProof Mycobacterium tuberculosis 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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58212</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:17.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304065</udiDi>
    <basicUdiDi>B-08595696304065</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Herpes Simplex Virus (HSV-1/2) PCR Kit</tradeName>
    <deviceName>GeneProof Herpes Simplex Virus (HSV-1/2) 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>A58128</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:16.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304058</udiDi>
    <basicUdiDi>B-08595696304058</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Ureaplasma PCR Kit</tradeName>
    <deviceName>GeneProof Ureaplasma 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>A58127</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:15.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304041</udiDi>
    <basicUdiDi>B-08595696304041</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Trichomonas vaginalis PCR Kit</tradeName>
    <deviceName>GeneProof Trichomonas vaginalis 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>A58126</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:12.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304034</udiDi>
    <basicUdiDi>B-08595696304034</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Treponema pallidum PCR Kit</tradeName>
    <deviceName>GeneProof Treponema pallidum 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>W0105010305</emdnCode>
    <emdnDescription>SYPHILIS DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58125</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:11.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304003</udiDi>
    <basicUdiDi>B-08595696304003</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Mycoplasma genitalium/hominis PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma genitalium/hominis 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>A58122</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:10.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696303983</udiDi>
    <basicUdiDi>B-08595696303983</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Human Papillomavirus (HPV) Screening PCR Kit</tradeName>
    <deviceName>GeneProof Human Papillomavirus (HPV) Screening 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>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58120</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:08.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696303976</udiDi>
    <basicUdiDi>B-08595696303976</basicUdiDi>
    <tradeName>TaqPath™ Menu | 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>A58119</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:06.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696303969</udiDi>
    <basicUdiDi>B-08595696303969</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Gardnerella vaginalis PCR Kit</tradeName>
    <deviceName>GeneProof Gardnerella vaginalis 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>A58118</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:04.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302733</udiDi>
    <basicUdiDi>B-08595696302733</basicUdiDi>
    <tradeName>GeneProof MTHFR C677T MC PCR Kit</tradeName>
    <deviceName>GeneProof MTHFR C677T 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>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M677/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:03.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302726</udiDi>
    <basicUdiDi>B-08595696302726</basicUdiDi>
    <tradeName>GeneProof MTHFR A1298C MC PCR Kit</tradeName>
    <deviceName>GeneProof MTHFR A1298C 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>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1298/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:02.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302719</udiDi>
    <basicUdiDi>B-08595696302719</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/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:59.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302702</udiDi>
    <basicUdiDi>B-08595696302702</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/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:58.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302689</udiDi>
    <basicUdiDi>B-08595696302689</basicUdiDi>
    <tradeName>GeneProof PAI-1 Genotyping MC PCR Kit</tradeName>
    <deviceName>GeneProof PAI-1 Genotyping 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>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAI1/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:57.528Z</lastUpdated>
  </row>
</eudamedExport>