<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-693757995112QN</udiDi>
    <basicUdiDi>B-693757995112QN</basicUdiDi>
    <tradeName>Multiple Rapid Real-Time PCR kit for Detection of SARS-CoV-2 (Fluorescent PCR Method）</tradeName>
    <deviceName>Multiple Rapid Real-Time PCR kit for Detection of SARS-CoV-2 (Fluorescent PCR Method）</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>25 Tests / Kit, 1 Test / Package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:51:02.964Z</lastUpdated>
  </row>
  <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>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>08056771101141</udiDi>
    <basicUdiDi>B-08056771101141</basicUdiDi>
    <tradeName>LIAISON® Biotrin Parvovirus B19 IgG</tradeName>
    <deviceName>LIAISON® Biotrin Parvovirus B19 IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040609</emdnCode>
    <emdnDescription>PARVOVIRUS B 19</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>317000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:31:55.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975456580243</udiDi>
    <basicUdiDi>B-06975456580243</basicUdiDi>
    <tradeName>BNIBT</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test (Saliva)</deviceName>
    <manufacturerName>Beijing North Institute of Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008259</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RICOV7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:26:08.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974785750556</udiDi>
    <basicUdiDi>B-06974785750556</basicUdiDi>
    <tradeName>Dengue Ab and Ag Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Dengue Ab and Ag Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDEC-5023</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:49.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466106131</udiDi>
    <basicUdiDi>B-04099466106131</basicUdiDi>
    <tradeName>04099466106131</tradeName>
    <deviceName>Serazym® Norovirus</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:37.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466104533</udiDi>
    <basicUdiDi>B-04099466104533</basicUdiDi>
    <tradeName>04099466104533</tradeName>
    <deviceName>Serazym® Astrovirus</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040629</emdnCode>
    <emdnDescription>ASTROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:32.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIZVM0790DS0C</udiDi>
    <basicUdiDi>B-+ENTIZVM0790DS0C</basicUdiDi>
    <tradeName>+ENTIZVM0790DS0C</tradeName>
    <deviceName>NovaLisa® Zika Virus IgM μ-capture</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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZVM0790DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:54.581Z</lastUpdated>
  </row>
</eudamedExport>