<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FI-CSG-402BJ5</udiDi>
    <basicUdiDi>B-FI-CSG-402BJ5</basicUdiDi>
    <tradeName>COVID-19 S-RBD IgG Quantitative Test Cassette</tradeName>
    <deviceName>COVID-19 S-RBD IgG Quantitative Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-CSG-402B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:31:56.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-INCPG-411B9</udiDi>
    <basicUdiDi>B-INCPG-411B9</basicUdiDi>
    <tradeName>COVID-19 IgG Rapid Test</tradeName>
    <deviceName>COVID-19 IgG Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INCPG-411</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:29:50.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-INCPG-402B8</udiDi>
    <basicUdiDi>B-INCPG-402B8</basicUdiDi>
    <tradeName>COVID-19 IgG Rapid Test</tradeName>
    <deviceName>COVID-19 IgG Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INCPG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:29:49.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICNG-402CR</udiDi>
    <basicUdiDi>B-ICNG-402CR</basicUdiDi>
    <tradeName>COVID-19 Nucleocapsid Protein IgG Antibody Rapid Test</tradeName>
    <deviceName>COVID-19 Nucleocapsid Protein IgG Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICNG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:29:36.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-CSG-402Q9</udiDi>
    <basicUdiDi>B-FI-CSG-402Q9</basicUdiDi>
    <tradeName>COVID-19 S-RBD IgG Antibody Test Cassette</tradeName>
    <deviceName>COVID-19 S-RBD IgG Antibody Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-CSG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:20:01.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R209152P</udiDi>
    <basicUdiDi>B-R209152P</basicUdiDi>
    <tradeName>D-R209152P</tradeName>
    <deviceName>Novel CoronaVirus IgG Antibody  (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20915</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:32.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R209132K</udiDi>
    <basicUdiDi>B-R209132K</basicUdiDi>
    <tradeName>D-R209132K</tradeName>
    <deviceName>Novel CoronaVirus IgG Antibody  (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20913</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:28.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R209122H</udiDi>
    <basicUdiDi>B-R209122H</basicUdiDi>
    <tradeName>D-R209122H</tradeName>
    <deviceName>Novel CoronaVirus IgG Antibody  (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20912</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:27.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R209112F</udiDi>
    <basicUdiDi>B-R209112F</basicUdiDi>
    <tradeName>D-R209112F</tradeName>
    <deviceName>Novel CoronaVirus IgG Antibody  (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20911</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:26.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R208132E</udiDi>
    <basicUdiDi>B-R208132E</basicUdiDi>
    <tradeName>D-R208132E</tradeName>
    <deviceName>Novel CoronaVirus IgM Antibody (2019-nCoV IgM)  Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20813</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:21.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICVGQ09700B</udiDi>
    <basicUdiDi>B-+ENTICVGQ09700B</basicUdiDi>
    <tradeName>+ENTICVGQ09700B</tradeName>
    <deviceName>GSD NovaLisa SARS-CoV-2 (COVID-19) quantitative IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVGQ0970</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:10:55.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICOVG094006</udiDi>
    <basicUdiDi>B-+ENTICOVG094006</basicUdiDi>
    <tradeName>+ENTICOVG094006</tradeName>
    <deviceName>NovaLisa® SARS-CoV-2 (COVID-19) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVG0940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:10:42.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301774470T</udiDi>
    <basicUdiDi>B-+ENTI301774470T</basicUdiDi>
    <tradeName>+ENTI301774470T</tradeName>
    <deviceName>SARS-CoV-2 (COVID-19) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30177447</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:06:51.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVD47-02-1tJN</udiDi>
    <basicUdiDi>B-IVD47-02-1tJN</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>COVID-19 IgG Test kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD47-02-1t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:18.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-INCPG-R402CF</udiDi>
    <basicUdiDi>B-INCPG-R402CF</basicUdiDi>
    <tradeName>COVID-19 IgG Rapid Test</tradeName>
    <deviceName>COVID-19 IgG Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INCPG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:39:27.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICSG-R4028T</udiDi>
    <basicUdiDi>B-ICSG-R4028T</basicUdiDi>
    <tradeName>SARS-CoV-2 S-RBD IgG Antibody Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 S-RBD IgG Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICSG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:14.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICN-R402C2</udiDi>
    <basicUdiDi>B-ICN-R402C2</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralization Antibody Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICN-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:07.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008823</udiDi>
    <basicUdiDi>B-04050598008823</basicUdiDi>
    <tradeName>IDK® anti-SARS-CoV-2 IgG ELISA DBS</tradeName>
    <deviceName>IDK® anti-SARS-CoV-2 IgG ELISA DBS</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5004DBS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:53.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598007888</udiDi>
    <basicUdiDi>B-04050598007888</basicUdiDi>
    <tradeName>IDK® anti-SARS-CoV-2 IgG ELISA</tradeName>
    <deviceName>IDK® anti-SARS-CoV-2 IgG ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 5004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:45.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006188</udiDi>
    <basicUdiDi>B-04050598006188</basicUdiDi>
    <tradeName>IDK® anti-SARS-CoV-2 IgG ELISA</tradeName>
    <deviceName>IDK® anti-SARS-CoV-2 IgG ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 5000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:18.762Z</lastUpdated>
  </row>
</eudamedExport>