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    <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>
  </row>
  <row>
    <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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  <row>
    <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>
  <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>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>
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  <row>
    <udiDi>08594161958499</udiDi>
    <basicUdiDi>B-08594161958499</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/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:30.575Z</lastUpdated>
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  <row>
    <udiDi>08594161958482</udiDi>
    <basicUdiDi>B-08594161958482</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/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:28.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161958475</udiDi>
    <basicUdiDi>B-08594161958475</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/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:28.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161957003</udiDi>
    <basicUdiDi>B-08594161957003</basicUdiDi>
    <tradeName>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>M1298/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:08.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161956990</udiDi>
    <basicUdiDi>B-08594161956990</basicUdiDi>
    <tradeName>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>M677/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:07.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161957010</udiDi>
    <basicUdiDi>B-08594161957010</basicUdiDi>
    <tradeName>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>PAI1/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:06.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161955399</udiDi>
    <basicUdiDi>B-08594161955399</basicUdiDi>
    <tradeName>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>PAI1/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:36.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161955320</udiDi>
    <basicUdiDi>B-08594161955320</basicUdiDi>
    <tradeName>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>M677/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:34.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161955221</udiDi>
    <basicUdiDi>B-08594161955221</basicUdiDi>
    <tradeName>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>M1298/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:33.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040630488</udiDi>
    <basicUdiDi>B-07350040630488</basicUdiDi>
    <tradeName>Devyser Thrombophilia</tradeName>
    <deviceName>Devyser Thrombophilia</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</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>8-A035</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:02.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323012863</udiDi>
    <basicUdiDi>B-06974323012863</basicUdiDi>
    <tradeName>06974323012863</tradeName>
    <deviceName>Human MTHFR Gene Polymorphism Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>ID017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:49.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323012856</udiDi>
    <basicUdiDi>B-06974323012856</basicUdiDi>
    <tradeName>06974323012856</tradeName>
    <deviceName>Human MTHFR Gene Polymorphism Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>ID017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:47.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055002795</udiDi>
    <basicUdiDi>B-04049055002795</basicUdiDi>
    <tradeName>FluoroType® MTHFR C677T VER 1.0</tradeName>
    <deviceName>FluoroType® MTHFR C677T VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</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>60024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:04:05.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055002665</udiDi>
    <basicUdiDi>B-04049055002665</basicUdiDi>
    <tradeName>FluoroType® Factor II VER 1.0</tradeName>
    <deviceName>FluoroType® Factor II VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</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>60296</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:58.615Z</lastUpdated>
  </row>
</eudamedExport>