<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-693757995107QV</udiDi>
    <basicUdiDi>B-693757995107QV</basicUdiDi>
    <tradeName>SARS-CoV-2 Multiplex Antibody Rapid Test Kit</tradeName>
    <deviceName>SARS-CoV-2 Multiplex Antibody Rapid Test Kit</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Multiplex Antibody cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:58.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995106QT</udiDi>
    <basicUdiDi>B-693757995106QT</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Rapid Test Kit</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Rapid Test Kit</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SARS-CoV-2 Neutralizing Antibody cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:58.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995104QP</udiDi>
    <basicUdiDi>B-693757995104QP</basicUdiDi>
    <tradeName>SARS-CoV-2 Ag Duo Home</tradeName>
    <deviceName>SARS-CoV-2 Ag Duo Home</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SARS-CoV-2 Antigen cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:57.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995103QM</udiDi>
    <basicUdiDi>B-693757995103QM</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SARS-CoV-2 cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:56.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995101QH</udiDi>
    <basicUdiDi>B-693757995101QH</basicUdiDi>
    <tradeName>COVID-19 IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>COVID-19 IgG/IgM Rapid Test Kit</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>COVID-19 IgG/IgM cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:52.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995100QF</udiDi>
    <basicUdiDi>B-693757995100QF</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Test kit</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test kit</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SARS-CoV-2 Antigen cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:51.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>6970277510028JYX</udiDi>
    <basicUdiDi>B-6970277510028JYX</basicUdiDi>
    <tradeName>HPV Antigen Rapid Test Cassette</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105041001</emdnCode>
    <emdnDescription>HPV ANTIGEN / ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THPV-502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:33.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757993826RN</udiDi>
    <basicUdiDi>B-693757993826RN</basicUdiDi>
    <tradeName>SARS-CoV-2/Flu A+B Antigen Rapid Test(Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2/Flu A+B Antigen Rapid Test(Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:28.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757993824RJ</udiDi>
    <basicUdiDi>B-693757993824RJ</basicUdiDi>
    <tradeName>Novel Corona Virus Antigen/Respiratory Syncytial Virus Antigen/Adenovirus Antigen/Mycoplasma Pneumoniae Antigen/Influenza A/B virus AntigenTest Kit (Colloidal Gold)</tradeName>
    <deviceName>Novel Corona Virus Antigen/Respiratory Syncytial Virus Antigen/Adenovirus Antigen/Mycoplasma Pneumoniae Antigen/Influenza A/B virus AntigenTest Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:28.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757993818RP</udiDi>
    <basicUdiDi>B-693757993818RP</basicUdiDi>
    <tradeName>Antigens Multiplex(FluA-FluB-SARS-CoV-2)</tradeName>
    <deviceName>Antigens Multiplex(FluA-FluB-SARS-CoV-2)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FluA-FluB-SARS-CoV-2 cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:24.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757992103PY</udiDi>
    <basicUdiDi>B-693757992103PY</basicUdiDi>
    <tradeName>Dengue NS1/IgM/IgG test cassette</tradeName>
    <deviceName>Dengue NS1/IgM/IgG test cassette</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Dengue-NS1/IgM/IgG 252102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:19.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757992102PW</udiDi>
    <basicUdiDi>B-693757992102PW</basicUdiDi>
    <tradeName>Dengue NS1 antigen test cassette</tradeName>
    <deviceName>Dengue NS1 antigen test cassette</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Dengue-NS1 252102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:18.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757992101PU</udiDi>
    <basicUdiDi>B-693757992101PU</basicUdiDi>
    <tradeName>Dengue IgM/IgG test cassette</tradeName>
    <deviceName>Dengue IgM/IgG test cassette</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Dengue-IgM/IgG 252102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:17.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757990638QW</udiDi>
    <basicUdiDi>B-693757990638QW</basicUdiDi>
    <tradeName>SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test</tradeName>
    <deviceName>SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SARS-CoV-2/Flu A+B/RSV Antigen cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:05.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>58594036041023</udiDi>
    <basicUdiDi>B-58594036041023</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-CMV IgG (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040203</emdnCode>
    <emdnDescription>CMV IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-102/5ST</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:50:31.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5713915CD002LC9H</udiDi>
    <basicUdiDi>B-5713915CD002LC9H</basicUdiDi>
    <tradeName>CoviDetect</tradeName>
    <deviceName>CoviDetec FAST COVID-19 Multiplex RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8016; 8018; 8022</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:30.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5713915CD001LA98</udiDi>
    <basicUdiDi>B-5713915CD001LA98</basicUdiDi>
    <tradeName>CoviDetect</tradeName>
    <deviceName>CoviDetect COVID-19 Multiplex RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8015, 8010, 8079</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:29.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>58594036040910</udiDi>
    <basicUdiDi>B-58594036040910</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-VCA EBV IgG (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-091O</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:41:51.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>58594036040873</udiDi>
    <basicUdiDi>B-58594036040873</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-VZV IgG (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040902</emdnCode>
    <emdnDescription>VARICELLA ZOSTER VIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-087/5ST</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:41:48.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>5713915CD003LE9S</udiDi>
    <basicUdiDi>B-5713915CD003LE9S</basicUdiDi>
    <tradeName>CoviDetect</tradeName>
    <deviceName>CoviDetect™ ULTRA COVID-19 Multiplex RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8213, 8214</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:40:59.960Z</lastUpdated>
  </row>
</eudamedExport>