<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-1R04EK</udiDi>
    <basicUdiDi>B-1R04EK</basicUdiDi>
    <tradeName>mariPOC® Human coronavirus OC43 test reagent</tradeName>
    <deviceName>mariPOC® Human coronavirus OC43 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>1R04</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:55.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R03EH</udiDi>
    <basicUdiDi>B-1R03EH</basicUdiDi>
    <tradeName>mariPOC® Human bocavirus test reagent</tradeName>
    <deviceName>mariPOC® Human bocavirus 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>W0105040618</emdnCode>
    <emdnDescription>BOCAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R03</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:55.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R02EF</udiDi>
    <basicUdiDi>B-1R02EF</basicUdiDi>
    <tradeName>mariPOC® Group A streptococcus test reagent</tradeName>
    <deviceName>mariPOC® Group A streptococcus 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>1R02</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:54.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R01ED</udiDi>
    <basicUdiDi>B-1R01ED</basicUdiDi>
    <tradeName>mariPOC® Adenovirus respiratory test reagent</tradeName>
    <deviceName>mariPOC® Adenovirus 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>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R01</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:50.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1214MGG</udiDi>
    <basicUdiDi>B-1214MGG</basicUdiDi>
    <tradeName>mariPOC® Quick combi+ test plate</tradeName>
    <deviceName>mariPOC® Quick 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>1214M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:53:14.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1204SGP</udiDi>
    <basicUdiDi>B-1204SGP</basicUdiDi>
    <tradeName>mariPOC® SARS-CoV-2 test plate</tradeName>
    <deviceName>mariPOC® SARS-CoV-2 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1204S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:53:01.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1204SCQQ</udiDi>
    <basicUdiDi>B-1204SCQQ</basicUdiDi>
    <tradeName>mariPOC® SARS-2 control samples</tradeName>
    <deviceName>mariPOC® SARS-2 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>1204SC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:57.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1194MHH</udiDi>
    <basicUdiDi>B-1194MHH</basicUdiDi>
    <tradeName>mariPOC® RTI combi+ test plate</tradeName>
    <deviceName>mariPOC® RTI 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>1194M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:12.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1184MHC</udiDi>
    <basicUdiDi>B-1184MHC</basicUdiDi>
    <tradeName>mariPOC® Respi+ test plate</tradeName>
    <deviceName>mariPOC® Respi+ 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>1184M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:11.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1124MGE</udiDi>
    <basicUdiDi>B-1124MGE</basicUdiDi>
    <tradeName>mariPOC® Pharyn test plate</tradeName>
    <deviceName>mariPOC® Pharyn 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>1124M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:57.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1124MCQ9</udiDi>
    <basicUdiDi>B-1124MCQ9</basicUdiDi>
    <tradeName>mariPOC® Pharyn control samples</tradeName>
    <deviceName>mariPOC® Pharyn 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>1124MC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:55.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1104MCPT</udiDi>
    <basicUdiDi>B-1104MCPT</basicUdiDi>
    <tradeName>mariPOC® RTI control samples</tradeName>
    <deviceName>mariPOC® RTI 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>1104MC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:31.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430080370528</udiDi>
    <basicUdiDi>6430080371224MCCF</basicUdiDi>
    <tradeName>mariPOC® Quick Flu+ control samples</tradeName>
    <deviceName>mariPOC® Quick Flu+ control samples</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1224MC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:40.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430080370481</udiDi>
    <basicUdiDi>643008037A-44W9</basicUdiDi>
    <tradeName>mariPOC® Filtration unit rack</tradeName>
    <deviceName>mariPOC®  Filtration unit rack</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-44</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:40.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430080370474</udiDi>
    <basicUdiDi>643008037A-43W7</basicUdiDi>
    <tradeName>mariPOC® Test plate storage rack</tradeName>
    <deviceName>mariPOC®  Test plate storage rack</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-43</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:39.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430080370467</udiDi>
    <basicUdiDi>643008037A-29WD</basicUdiDi>
    <tradeName>mariPOC® Bottletop dispenser stand</tradeName>
    <deviceName>mariPOC® Bottletop dispenser stand</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-29</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:38.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430080370450</udiDi>
    <basicUdiDi>643008037A-99G</basicUdiDi>
    <tradeName>mariPOC® Waste container</tradeName>
    <deviceName>mariPOC® Waste container</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020280</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-9</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:37.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430080370443</udiDi>
    <basicUdiDi>643008037A-292</basicUdiDi>
    <tradeName>mariPOC®  Sample tube cap</tradeName>
    <deviceName>mariPOC®  Sample tube cap</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:36.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430080370436</udiDi>
    <basicUdiDi>643008037A-18Y</basicUdiDi>
    <tradeName>mariPOC® Sample tube</tradeName>
    <deviceName>mariPOC® Sample tube</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:36.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430080370429</udiDi>
    <basicUdiDi>643008037AD1-ST3</basicUdiDi>
    <tradeName>mariPOC® Software</tradeName>
    <deviceName>mariPOC® Software</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020292</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD1-S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:35.319Z</lastUpdated>
  </row>
</eudamedExport>