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<eudamedExport entity="devices">
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    <udiDi>08595696306526</udiDi>
    <basicUdiDi>859569630080QR</basicUdiDi>
    <tradeName>myCROBE® Fully Automated Instrument</tradeName>
    <deviceName>myCROBE® Fully Automated Instrument</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:55:38.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302955</udiDi>
    <basicUdiDi>859569630053QN</basicUdiDi>
    <tradeName>croBEE® 2.0 Nucleic Acid Extraction System</tradeName>
    <deviceName>croBEE® 2.0 Nucleic Acid Extraction System</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CB2NA100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:55:37.376Z</lastUpdated>
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    <udiDi>08595696302450</udiDi>
    <basicUdiDi>859569630047QT</basicUdiDi>
    <tradeName>croBEE Real-Time PCR System</tradeName>
    <deviceName>croBEE Real-Time PCR System</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBRT5/96</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:55:34.110Z</lastUpdated>
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  <row>
    <udiDi>08595696300050</udiDi>
    <basicUdiDi>859569630052QL</basicUdiDi>
    <tradeName>myCROBE® Fully Automated Instrument</tradeName>
    <deviceName>myCROBE® Fully Automated Instrument</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:55:32.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696305772</udiDi>
    <basicUdiDi>859569630077R4</basicUdiDi>
    <tradeName>croGENE Real-Time PCR System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGRT6/96</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:31.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302467</udiDi>
    <basicUdiDi>859569630047QT</basicUdiDi>
    <tradeName>croBEE Real-Time PCR System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBRT4/96</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:13.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696303891</udiDi>
    <basicUdiDi>859569630055QS</basicUdiDi>
    <tradeName>GeneProof Cytomegalovirus (CMV) MC PCR Kit</tradeName>
    <deviceName>GeneProof Cytomegalovirus (CMV) MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMV/MC/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:33:15.749Z</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>08595696304430</udiDi>
    <basicUdiDi>B-08595696304430</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ JC Virus (JCV) PCR Kit</tradeName>
    <deviceName>GeneProof JC Virus (JCV) 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>A58436</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:00:00.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304393</udiDi>
    <basicUdiDi>B-08595696304393</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Varicella-Zoster Virus (VZV) PCR Kit</tradeName>
    <deviceName>GeneProof Varicella-Zoster Virus (VZV) 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>A58432</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:57.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304423</udiDi>
    <basicUdiDi>B-08595696304423</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Parvovirus B19 PCR Kit</tradeName>
    <deviceName>GeneProof Parvovirus B19 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>W0105040509</emdnCode>
    <emdnDescription>PARVOVIRUS B 19 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58435</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:56.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304379</udiDi>
    <basicUdiDi>B-08595696304379</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ BK Virus (BKV) PCR Kit</tradeName>
    <deviceName>GeneProof BK Virus (BKV) 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>A58430</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:55.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304386</udiDi>
    <basicUdiDi>B-08595696304386</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ BK/JC Virus (BK/JC) PCR Kit</tradeName>
    <deviceName>GeneProof BK/JC Virus (BK/JC) 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>A58431</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:53.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304362</udiDi>
    <basicUdiDi>B-08595696304362</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Epstein-Barr Virus (EBV) PCR Kit</tradeName>
    <deviceName>GeneProof Epstein-Barr Virus (EBV) 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>A58429</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:38.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304348</udiDi>
    <basicUdiDi>B-08595696304348</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Hepatitis C Virus (HCV) Diagnostic PCR Kit</tradeName>
    <deviceName>GeneProof Hepatitis C Virus (HCV) 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>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58427</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:36.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304331</udiDi>
    <basicUdiDi>B-08595696304331</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Hepatitis B Virus (HBV) PCR Kit</tradeName>
    <deviceName>GeneProof Hepatitis B Virus (HBV) 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>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58426</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:35.965Z</lastUpdated>
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    <udiDi>08595696304324</udiDi>
    <basicUdiDi>B-08595696304324</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ MTHFR A1298C PCR Kit</tradeName>
    <deviceName>GeneProof MTHFR A1298C 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>A58425</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:34.353Z</lastUpdated>
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    <udiDi>08595696304317</udiDi>
    <basicUdiDi>B-08595696304317</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ MTHFR C677T PCR Kit</tradeName>
    <deviceName>GeneProof MTHFR C677T 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>A58424</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:31.949Z</lastUpdated>
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    <udiDi>08595696304300</udiDi>
    <basicUdiDi>B-08595696304300</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ PAI1 Genotyping PCR Kit</tradeName>
    <deviceName>GeneProof PAI1 Genotyping 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>A58423</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:30.349Z</lastUpdated>
  </row>
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    <udiDi>08595696304294</udiDi>
    <basicUdiDi>B-08595696304294</basicUdiDi>
    <tradeName>TaqPath™ Menu | 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>A58422</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:29.547Z</lastUpdated>
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