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    <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>
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    <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>
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    <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>
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    <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>
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  <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>
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  <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>
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  <row>
    <udiDi>06930317801394</udiDi>
    <basicUdiDi>B-06930317801394</basicUdiDi>
    <tradeName>06930317801394</tradeName>
    <deviceName>QuicNATM SARS-CoV-2 Neutralization 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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:35:45.636Z</lastUpdated>
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  <row>
    <udiDi>06930317801387</udiDi>
    <basicUdiDi>B-06930317801387</basicUdiDi>
    <tradeName>06930317801387</tradeName>
    <deviceName>QuicNATM SARS-CoV-2 Neutralization 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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:35:44.837Z</lastUpdated>
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  <row>
    <udiDi>06930317801370</udiDi>
    <basicUdiDi>B-06930317801370</basicUdiDi>
    <tradeName>06930317801370</tradeName>
    <deviceName>QuicNATM SARS-CoV-2 Neutralization 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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:35:43.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801363</udiDi>
    <basicUdiDi>B-06930317801363</basicUdiDi>
    <tradeName>06930317801363</tradeName>
    <deviceName>Dynamiker SARS-CoV-2 Neutralization Antibody 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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2101-1</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:35:42.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801325</udiDi>
    <basicUdiDi>B-06930317801325</basicUdiDi>
    <tradeName>06930317801325</tradeName>
    <deviceName>Dynamiker SARS-CoV-2 Ag Rapid Test(Nasal Swab)</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-1425-1N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:35:36.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317801318</udiDi>
    <basicUdiDi>B-06930317801318</basicUdiDi>
    <tradeName>06930317801318</tradeName>
    <deviceName>Dynamiker SARS-CoV-2 Ag Rapid Test (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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2105-1</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:35:35.233Z</lastUpdated>
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  <row>
    <udiDi>06930317801301</udiDi>
    <basicUdiDi>B-06930317801301</basicUdiDi>
    <tradeName>06930317801301</tradeName>
    <deviceName>Dynamiker SARS-CoV-2 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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1425-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:35:31.224Z</lastUpdated>
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  <row>
    <udiDi>06930317801295</udiDi>
    <basicUdiDi>B-06930317801295</basicUdiDi>
    <tradeName>06930317801295</tradeName>
    <deviceName>2019-nCoV IgG/IgM 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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1419-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:35:30.435Z</lastUpdated>
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  <row>
    <udiDi>06930317800663</udiDi>
    <basicUdiDi>B-06930317800663</basicUdiDi>
    <tradeName>06930317800663</tradeName>
    <deviceName>Dynamiker SARS-CoV-2 Ag Rapid Test</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>PureCE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006069</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1425-5N</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:34:25.931Z</lastUpdated>
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  <row>
    <udiDi>06928103014318</udiDi>
    <basicUdiDi>B-06928103014318</basicUdiDi>
    <tradeName>06928103014318</tradeName>
    <deviceName>Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</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>DA1431</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:31:35.795Z</lastUpdated>
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  <row>
    <udiDi>06928103014301</udiDi>
    <basicUdiDi>B-06928103014301</basicUdiDi>
    <tradeName>06928103014301</tradeName>
    <deviceName>Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</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>DA1430</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:31:34.985Z</lastUpdated>
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  <row>
    <udiDi>06928103013915</udiDi>
    <basicUdiDi>B-06928103013915</basicUdiDi>
    <tradeName>06928103013915</tradeName>
    <deviceName>Detection Kit for 2019-nCoV Nucleic Acid (Thermostatic Amplification-LFIA)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</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>DA1391</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:31:31.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103013908</udiDi>
    <basicUdiDi>B-06928103013908</basicUdiDi>
    <tradeName>06928103013908</tradeName>
    <deviceName>Detection Kit for 2019-nCoV Nucleic Acid (Thermostatic Amplification-LFIA)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</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>DA1390</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:31:30.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103012529</udiDi>
    <basicUdiDi>B-06928103012529</basicUdiDi>
    <tradeName>06928103012529</tradeName>
    <deviceName>Detection Kit for Epstein-Barr Virus Nucleic Acid (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:31:14.914Z</lastUpdated>
  </row>
</eudamedExport>