<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>38594036043139</udiDi>
    <basicUdiDi>B-38594036043139</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-TBEV IgG avidity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-313-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:37.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>38594036043115</udiDi>
    <basicUdiDi>B-38594036043115</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-TBEV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-311-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:36.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>38594036043108</udiDi>
    <basicUdiDi>B-38594036043108</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-TBEV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-310-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:34.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2R07EY</udiDi>
    <basicUdiDi>B-2R07EY</basicUdiDi>
    <tradeName>mariPOC® Rotavirus test reagent</tradeName>
    <deviceName>mariPOC® Rotavirus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R07</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:41.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2R06EW</udiDi>
    <basicUdiDi>B-2R06EW</basicUdiDi>
    <tradeName>mariPOC® Norovirus GII.4 test reagent</tradeName>
    <deviceName>mariPOC® Norovirus GII.4 test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R06</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:41.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2R05EU</udiDi>
    <basicUdiDi>B-2R05EU</basicUdiDi>
    <tradeName>mariPOC® Norovirus GI test reagent</tradeName>
    <deviceName>mariPOC® Norovirus GI test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R05</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:38.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2R01EL</udiDi>
    <basicUdiDi>B-2R01EL</basicUdiDi>
    <tradeName>mariPOC® Adenovirus gastrointestinal test reagent</tradeName>
    <deviceName>mariPOC® Adenovirus gastrointestinal test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R01</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:33.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036044504</udiDi>
    <basicUdiDi>B-28594036044504</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-JCV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040623</emdnCode>
    <emdnDescription>JC VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-450</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:57.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036044054</udiDi>
    <basicUdiDi>B-28594036044054</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-BKV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040622</emdnCode>
    <emdnDescription>BK VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-405</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:56.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036041947</udiDi>
    <basicUdiDi>B-28594036041947</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-TBEV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-194</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:13.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036041923</udiDi>
    <basicUdiDi>B-28594036041923</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-TBEV IgG (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-192</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:12.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036041701</udiDi>
    <basicUdiDi>B-28594036041701</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-TBEV IgG and IgG avidity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-170</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:06.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R13EL</udiDi>
    <basicUdiDi>B-1R13EL</basicUdiDi>
    <tradeName>mariPOC® SARS-CoV-2 test reagent</tradeName>
    <deviceName>mariPOC® SARS-CoV-2 test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R13</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:16.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R12EJ</udiDi>
    <basicUdiDi>B-1R12EJ</basicUdiDi>
    <tradeName>mariPOC® Respiratory syncytial virus test reagent</tradeName>
    <deviceName>mariPOC® Respiratory syncytial virus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040605</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R12</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:15.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R10EE</udiDi>
    <basicUdiDi>B-1R10EE</basicUdiDi>
    <tradeName>mariPOC® Parainfluenza virus 3 test reagent</tradeName>
    <deviceName>mariPOC® Parainfluenza virus 3 test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R10</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:11.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R09EV</udiDi>
    <basicUdiDi>B-1R09EV</basicUdiDi>
    <tradeName>mariPOC® Parainfluenza virus 2 test reagent</tradeName>
    <deviceName>mariPOC® Parainfluenza virus 2 test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R09</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:10.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R08ET</udiDi>
    <basicUdiDi>B-1R08ET</basicUdiDi>
    <tradeName>mariPOC® Parainfluenza virus 1 test reagent</tradeName>
    <deviceName>mariPOC® Parainfluenza virus 1 test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R08</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:18:01.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R07ER</udiDi>
    <basicUdiDi>B-1R07ER</basicUdiDi>
    <tradeName>mariPOC® Influenza B virus test reagent</tradeName>
    <deviceName>mariPOC® Influenza B virus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R07</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:18:01.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R06EP</udiDi>
    <basicUdiDi>B-1R06EP</basicUdiDi>
    <tradeName>mariPOC® Influenza A virus test reagent</tradeName>
    <deviceName>mariPOC® Influenza A virus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R06</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:59.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R05EM</udiDi>
    <basicUdiDi>B-1R05EM</basicUdiDi>
    <tradeName>mariPOC® Human metapneumovirus test reagent</tradeName>
    <deviceName>mariPOC® Human metapneumovirus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040617</emdnCode>
    <emdnDescription>HUMAN METAPNEUMOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R05</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:56.440Z</lastUpdated>
  </row>
</eudamedExport>