<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>06950996004114</udiDi>
    <basicUdiDi>69509960GCFRA-T525aDRH3A</basicUdiDi>
    <tradeName>Rapid Flu A&amp;B+RSV+Adeno Antigen Test</tradeName>
    <deviceName>Rapid Flu A&amp;B+RSV+Adeno Antigen Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFRA-T525a-DRH20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:25.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004107</udiDi>
    <basicUdiDi>69509960GCFRA-T525aDRH3A</basicUdiDi>
    <tradeName>Rapid Flu A&amp;B+RSV+Adeno Antigen Test</tradeName>
    <deviceName>Rapid Flu A&amp;B+RSV+Adeno Antigen Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFRA-T525a-DRH7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:24.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004091</udiDi>
    <basicUdiDi>69509960GCFRA-T525aDRH3A</basicUdiDi>
    <tradeName>Rapid Flu A&amp;B+RSV+Adeno Antigen Test</tradeName>
    <deviceName>Rapid Flu A&amp;B+RSV+Adeno Antigen Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFRA-T525a-DRH5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:18.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004084</udiDi>
    <basicUdiDi>69509960GCFRA-T525aDRH3A</basicUdiDi>
    <tradeName>Rapid Flu A&amp;B+RSV+Adeno Antigen Test</tradeName>
    <deviceName>Rapid Flu A&amp;B+RSV+Adeno Antigen Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFRA-T525a-DRH1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:17.401Z</lastUpdated>
  </row>
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