<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-693757992101PU</udiDi>
    <basicUdiDi>B-693757992101PU</basicUdiDi>
    <tradeName>Dengue IgM/IgG test cassette</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Dengue-IgM/IgG 252102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757992102PW</udiDi>
    <basicUdiDi>B-693757992102PW</basicUdiDi>
    <tradeName>Dengue NS1 antigen test cassette</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Dengue-NS1 252102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757992103PY</udiDi>
    <basicUdiDi>B-693757992103PY</basicUdiDi>
    <tradeName>Dengue NS1/IgM/IgG test cassette</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Dengue-NS1/IgM/IgG 252102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757992601QM</udiDi>
    <basicUdiDi>B-693757992601QM</basicUdiDi>
    <tradeName>Multiple Drugs of Abuse Rapid Tests</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Multiple Drugs of Abuse strip cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757992602QP</udiDi>
    <basicUdiDi>B-693757992602QP</basicUdiDi>
    <tradeName>Multiple Drugs of Abuse Rapid Tests</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Multiple Drugs of Abuse Rapid strip  cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757993818RP</udiDi>
    <basicUdiDi>B-693757993818RP</basicUdiDi>
    <tradeName>Antigens Multiplex(FluA-FluB-SARS-CoV-2)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FluA-FluB-SARS-CoV-2 cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757993821RC</udiDi>
    <basicUdiDi>B-693757993821RC</basicUdiDi>
    <tradeName>Influenza A/Influenza B (FluA+B) Antigens Rapid Test Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Flu Cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.600Z</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></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.582Z</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></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995100QF</udiDi>
    <basicUdiDi>B-693757995100QF</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Test kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SARS-CoV-2 Antigen cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995101QH</udiDi>
    <basicUdiDi>B-693757995101QH</basicUdiDi>
    <tradeName>COVID-19 IgG/IgM Rapid Test Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>COVID-19 IgG/IgM cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995103QM</udiDi>
    <basicUdiDi>B-693757995103QM</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SARS-CoV-2 cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995104QP</udiDi>
    <basicUdiDi>B-693757995104QP</basicUdiDi>
    <tradeName>SARS-CoV-2 Ag Duo Home</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SARS-CoV-2 Antigen cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995106QT</udiDi>
    <basicUdiDi>B-693757995106QT</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Rapid Test Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SARS-CoV-2 Neutralizing Antibody cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995107QV</udiDi>
    <basicUdiDi>B-693757995107QV</basicUdiDi>
    <tradeName>SARS-CoV-2 Multiplex Antibody Rapid Test Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Multiplex Antibody cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.460Z</lastUpdated>
  </row>
  <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></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>25 Tests / Kit, 1 Test / Package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995501R5</udiDi>
    <basicUdiDi>B-693757995501R5</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MPV  Antigen  Cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995502R7</udiDi>
    <basicUdiDi>B-693757995502R7</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) IgG/IgM Antibody Test Kit (Colloidal Gold)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MPV IgG/IgM Antibody cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757995503R9</udiDi>
    <basicUdiDi>B-693757995503R9</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Nucleic Acid Test Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MPV Nucleic Acid Detection cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757997046RG</udiDi>
    <basicUdiDi>B-693757997046RG</basicUdiDi>
    <tradeName>Reaction Tube With Cap</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0.2 ml single  0.2ml 8 strips</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:27.379Z</lastUpdated>
  </row>
</eudamedExport>