<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>06430080370009</udiDi>
    <basicUdiDi>6430080371114MJ9</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1114M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:12.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816643</udiDi>
    <basicUdiDi>B-06952804816643</basicUdiDi>
    <tradeName>Rotavirus＆Adenovirus Antigen Fecal Combo Test Kit</tradeName>
    <deviceName>Rotavirus＆Adenovirus Antigen Fecal Combo Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI-F42001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:28.039Z</lastUpdated>
  </row>
</eudamedExport>