<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCCOV-501aHG49</udiDi>
    <basicUdiDi>B-GCCOV-501aHG49</basicUdiDi>
    <tradeName>Rapid COVID-19 Antigen Test Strip</tradeName>
    <deviceName>Rapid COVID-19 Antigen Test Strip</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-501a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:16.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-501a47</udiDi>
    <basicUdiDi>B-GCCOV-501a47</basicUdiDi>
    <tradeName>Rapid COVID-19 Antigen Test Strip</tradeName>
    <deviceName>Rapid COVID-19 Antigen Test Strip</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-501a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:15.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(Del)-T502aUL</udiDi>
    <basicUdiDi>B-GCCOV(Del)-T502aUL</basicUdiDi>
    <tradeName>SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>SARS-CoV-2 Delta-series Mutant Strain Ag 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Del)-T502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:50.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(Del)-T502aHGQG</udiDi>
    <basicUdiDi>B-GCCOV(Del)-T502aHGQG</basicUdiDi>
    <tradeName>SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Del)-T502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:49.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(B117)-525aKE</udiDi>
    <basicUdiDi>B-GCCOV(B117)-525aKE</basicUdiDi>
    <tradeName>COVID-19 Ag &amp; B.1.1.7 Mutant Strain Combo Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19 Ag &amp; B.1.1.7 Mutant Strain Combo 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(B117)-525a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:49.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(B117)-525aHGE5</udiDi>
    <basicUdiDi>B-GCCOV(B117)-525aHGE5</basicUdiDi>
    <tradeName>COVID-19 Ag &amp; B.1.1.7 Mutant Strain Combo Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19 Ag &amp; B.1.1.7 Mutant Strain Combo Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(B117)-525a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:45.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCCOV-502aHG3B</udiDi>
    <basicUdiDi>B-FCCOV-502aHG3B</basicUdiDi>
    <tradeName>SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)</tradeName>
    <deviceName>SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCCOV-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:18:11.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCCOV-502a3D</udiDi>
    <basicUdiDi>B-FCCOV-502a3D</basicUdiDi>
    <tradeName>SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)</tradeName>
    <deviceName>SARS-CoV-2 Ag Fluorescence 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCCOV-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:18:10.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-COVID-502bA5</udiDi>
    <basicUdiDi>B-COVID-502bA5</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test</deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVID-502b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:19:53.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-COVID-19-B026L</udiDi>
    <basicUdiDi>B-COVID-19-B026L</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVID-19-B02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:19:52.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>86979834610580</udiDi>
    <basicUdiDi>B-86979834610580</basicUdiDi>
    <tradeName>COVID 19 Antigen Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>COVID 19 Antigen Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>OSMUNDA Medical Technology Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009285</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVRAG89</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:23:06.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763037</udiDi>
    <basicUdiDi>B-15065023763037</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:33:56.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664840</udiDi>
    <basicUdiDi>B-08806134664840</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:10:01.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664833</udiDi>
    <basicUdiDi>B-08806134664833</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:10:01.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664826</udiDi>
    <basicUdiDi>B-08806134664826</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:56.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664819</udiDi>
    <basicUdiDi>B-08806134664819</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:55.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664345</udiDi>
    <basicUdiDi>B-08806134664345</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:55.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664338</udiDi>
    <basicUdiDi>B-08806134664338</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:53.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664321</udiDi>
    <basicUdiDi>B-08806134664321</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:49.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664314</udiDi>
    <basicUdiDi>B-08806134664314</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:48.957Z</lastUpdated>
  </row>
</eudamedExport>