<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-2R04ES</udiDi>
    <basicUdiDi>B-2R04ES</basicUdiDi>
    <tradeName>mariPOC® Clostridium difficile Toxin A/B test reagent</tradeName>
    <deviceName>mariPOC® Clostridium difficile Toxin A/B 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>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R04</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:35.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2R03EQ</udiDi>
    <basicUdiDi>B-2R03EQ</basicUdiDi>
    <tradeName>mariPOC® Clostridium difficile GDH test reagent</tradeName>
    <deviceName>mariPOC® Clostridium difficile GDH 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>W0105011801</emdnCode>
    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R03</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:34.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2R02EN</udiDi>
    <basicUdiDi>B-2R02EN</basicUdiDi>
    <tradeName>mariPOC® Campylobacter spp. test reagent</tradeName>
    <deviceName>mariPOC® Campylobacter spp. 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>W0105011401</emdnCode>
    <emdnDescription>CAMPYLOBACTER DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R02</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:34.009Z</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>D-2037MGY</udiDi>
    <basicUdiDi>B-2037MGY</basicUdiDi>
    <tradeName>mariPOC® CDI test plate</tradeName>
    <deviceName>mariPOC® CDI test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:11.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2027MGT</udiDi>
    <basicUdiDi>B-2027MGT</basicUdiDi>
    <tradeName>mariPOC® Gastro CDI combi test plate</tradeName>
    <deviceName>mariPOC® Gastro CDI combi test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2027M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:04.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2017MGN</udiDi>
    <basicUdiDi>B-2017MGN</basicUdiDi>
    <tradeName>mariPOC® Gastro test plate</tradeName>
    <deviceName>mariPOC® Gastro test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2017M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:55.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2017MCQK</udiDi>
    <basicUdiDi>B-2017MCQK</basicUdiDi>
    <tradeName>mariPOC® Gastro control samples</tradeName>
    <deviceName>mariPOC® Gastro control samples</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2017MC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:36.263Z</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-1R11EG</udiDi>
    <basicUdiDi>B-1R11EG</basicUdiDi>
    <tradeName>mariPOC® Pneumococcus respiratory test reagent</tradeName>
    <deviceName>mariPOC® Pneumococcus respiratory 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>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R11</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:11.990Z</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>