<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06950996002332</udiDi>
    <basicUdiDi>69509960GCFC-T502a-HSQ</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</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>GCFC-T502a-H20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:26.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002325</udiDi>
    <basicUdiDi>69509960GCFC-T502a-HSQ</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</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>GCFC-T502a-H7</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:20.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002318</udiDi>
    <basicUdiDi>69509960GCFC-T502a-HSQ</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</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>GCFC-T502a-H5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:19.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002301</udiDi>
    <basicUdiDi>69509960GCFC-T502a-HSQ</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</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>GCFC-T502a-H4</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:18.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002295</udiDi>
    <basicUdiDi>69509960GCFC-T502a-HSQ</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</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>GCFC-T502a-H2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:16.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002288</udiDi>
    <basicUdiDi>69509960GCFC-T502a-HSQ</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</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>GCFC-T502a-H1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:11.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002271</udiDi>
    <basicUdiDi>69509960GCFC-T502a-DRHJ</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B Ag Combo Rapid Test Cassette (Swab)</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFC-T502a-DR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:10.285Z</lastUpdated>
  </row>
</eudamedExport>