<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06930317802117</udiDi>
    <basicUdiDi>B-06930317802117</basicUdiDi>
    <tradeName>06930317802117</tradeName>
    <deviceName>2019-nCOV IgM Antibody kit (ELISA)</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</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>DNK-1421-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:37:12.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317802100</udiDi>
    <basicUdiDi>B-06930317802100</basicUdiDi>
    <tradeName>06930317802100</tradeName>
    <deviceName>2019-nCOV IgM Antibody kit (ELISA)</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</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>DNK-1421-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:37:11.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317802094</udiDi>
    <basicUdiDi>B-06930317802094</basicUdiDi>
    <tradeName>06930317802094</tradeName>
    <deviceName>Monkeypox Virus Real-time PCR Kit</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2115-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:37:04.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317802025</udiDi>
    <basicUdiDi>B-06930317802025</basicUdiDi>
    <tradeName>06930317802025</tradeName>
    <deviceName>QuicAbTM Talaromyces marneffei Ab Lateral Flow Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-17</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:44.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801967</udiDi>
    <basicUdiDi>B-06930317801967</basicUdiDi>
    <tradeName>06930317801967</tradeName>
    <deviceName>Dynamiker SARS-CoV-2 Lyophilized RT-PCR Kit</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-19</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:38.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801950</udiDi>
    <basicUdiDi>B-06930317801950</basicUdiDi>
    <tradeName>06930317801950</tradeName>
    <deviceName>MycoMDx Talaromyces marneffei PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2110-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:37.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801943</udiDi>
    <basicUdiDi>B-06930317801943</basicUdiDi>
    <tradeName>06930317801943</tradeName>
    <deviceName>MycoMDx Pneumocystis jirovecii (PJP) PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2109-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:33.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801936</udiDi>
    <basicUdiDi>B-06930317801936</basicUdiDi>
    <tradeName>06930317801936</tradeName>
    <deviceName>MycoMDx Mucor PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2108-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:32.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801912</udiDi>
    <basicUdiDi>B-06930317801912</basicUdiDi>
    <tradeName>06930317801912</tradeName>
    <deviceName>MycoMDx Candida auris PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2107-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:32.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801905</udiDi>
    <basicUdiDi>B-06930317801905</basicUdiDi>
    <tradeName>06930317801905</tradeName>
    <deviceName>MycoMDx Candida PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1417-1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:31.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801882</udiDi>
    <basicUdiDi>B-06930317801882</basicUdiDi>
    <tradeName>06930317801882</tradeName>
    <deviceName>MycoMDx Aspergillus PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1416-1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:27.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801875</udiDi>
    <basicUdiDi>B-06930317801875</basicUdiDi>
    <tradeName>06930317801875</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) RT-PCR Kit (Saliva)</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2106-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:26.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801868</udiDi>
    <basicUdiDi>B-06930317801868</basicUdiDi>
    <tradeName>06930317801868</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) RT PCR Kit</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1418-1</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:25.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801851</udiDi>
    <basicUdiDi>B-06930317801851</basicUdiDi>
    <tradeName>06930317801851</tradeName>
    <deviceName>Dynamiker Monkeypox Virus Ag Rapid Test</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2114-1</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:24.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801783</udiDi>
    <basicUdiDi>B-06930317801783</basicUdiDi>
    <tradeName>06930317801783</tradeName>
    <deviceName>QuicGXMTM Cryptococcus neoformans Ag Lateral Flow Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2113-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:20.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801608</udiDi>
    <basicUdiDi>B-06930317801608</basicUdiDi>
    <tradeName>06930317801608</tradeName>
    <deviceName>Dynamiker Candida IgG Lateral Flow Assay( LFA)</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1413-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:16.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801585</udiDi>
    <basicUdiDi>B-06930317801585</basicUdiDi>
    <tradeName>06930317801585</tradeName>
    <deviceName>QuicIgGTM Candida IgG Ab Lateral Flow Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2111-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:12.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801523</udiDi>
    <basicUdiDi>B-06930317801523</basicUdiDi>
    <tradeName>06930317801523</tradeName>
    <deviceName>QuicMnTM Candida Mannan Ag Lateral Flow Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2112-1</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:11.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801486</udiDi>
    <basicUdiDi>B-06930317801486</basicUdiDi>
    <tradeName>06930317801486</tradeName>
    <deviceName>QuicIgGTM Aspergillus IgG Ab Lateral Flow Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1415-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:10.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801462</udiDi>
    <basicUdiDi>B-06930317801462</basicUdiDi>
    <tradeName>06930317801462</tradeName>
    <deviceName>QuicGTM Fungus (1-3)-β-D-Glucan Lateral Flow Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2301-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:36:04.185Z</lastUpdated>
  </row>
</eudamedExport>