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<eudamedExport entity="devices">
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    <udiDi>06930317811843</udiDi>
    <basicUdiDi>B-06930317811843</basicUdiDi>
    <tradeName>06930317811843</tradeName>
    <deviceName>2019-nCOV IgM Antibody kit (Chemiluminescence)</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-1423-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:40:15.834Z</lastUpdated>
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  <row>
    <udiDi>06930317808522</udiDi>
    <basicUdiDi>B-06930317808522</basicUdiDi>
    <tradeName>06930317808522</tradeName>
    <deviceName>Dynamiker COVID-19/Influenza A+B Ag Combo 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>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2104-1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:40:14.899Z</lastUpdated>
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    <udiDi>06930317807846</udiDi>
    <basicUdiDi>B-06930317807846</basicUdiDi>
    <tradeName>06930317807846</tradeName>
    <deviceName>MycoMDx Mucor Cartridge PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2604-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:40:14.172Z</lastUpdated>
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    <udiDi>06930317807815</udiDi>
    <basicUdiDi>B-06930317807815</basicUdiDi>
    <tradeName>06930317807815</tradeName>
    <deviceName>MycoMDx Pneumocystis jirovecii Cartridge PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060405</emdnCode>
    <emdnDescription>PNEUMOCYSTIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2605-2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:40:09.859Z</lastUpdated>
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  <row>
    <udiDi>06930317807747</udiDi>
    <basicUdiDi>B-06930317807747</basicUdiDi>
    <tradeName>06930317807747</tradeName>
    <deviceName>Dynamiker Influenza A Antigen Assay (POCT Chemiluminescence)</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>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-55</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:56.698Z</lastUpdated>
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  <row>
    <udiDi>06930317807310</udiDi>
    <basicUdiDi>B-06930317807310</basicUdiDi>
    <tradeName>06930317807310</tradeName>
    <deviceName>2019-nCOV IgG Antibody kit (Chemiluminescence)</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-1422-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:51.114Z</lastUpdated>
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    <udiDi>06930317806955</udiDi>
    <basicUdiDi>B-06930317806955</basicUdiDi>
    <tradeName>06930317806955</tradeName>
    <deviceName>MycoMDx Candida Cartridge PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2602-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:48.697Z</lastUpdated>
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  <row>
    <udiDi>06930317806931</udiDi>
    <basicUdiDi>B-06930317806931</basicUdiDi>
    <tradeName>06930317806931</tradeName>
    <deviceName>MycoMDx Candida Cartridge PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2602-2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:47.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317806924</udiDi>
    <basicUdiDi>B-06930317806924</basicUdiDi>
    <tradeName>06930317806924</tradeName>
    <deviceName>MycoMDx Candida auris Cartridge PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060404</emdnCode>
    <emdnDescription>CANDIDA AURIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2603-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:46.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317806917</udiDi>
    <basicUdiDi>B-06930317806917</basicUdiDi>
    <tradeName>06930317806917</tradeName>
    <deviceName>MycoMDx Candida auris Cartridge PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060404</emdnCode>
    <emdnDescription>CANDIDA AURIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2603-2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:44.696Z</lastUpdated>
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  <row>
    <udiDi>06930317806719</udiDi>
    <basicUdiDi>B-06930317806719</basicUdiDi>
    <tradeName>06930317806719</tradeName>
    <deviceName>MycoMDx  Aspergillus Cartridge PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2601-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:42.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317806702</udiDi>
    <basicUdiDi>B-06930317806702</basicUdiDi>
    <tradeName>06930317806702</tradeName>
    <deviceName>MycoMDx  Aspergillus Cartridge PCR Assay</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2601-2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:40.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317805873</udiDi>
    <basicUdiDi>B-06930317805873</basicUdiDi>
    <tradeName>06930317805873</tradeName>
    <deviceName>Dynamiker Candida Mannan Assay (POCT Chemiluminescence)</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-1901-59</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:40.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930317804333</udiDi>
    <basicUdiDi>B-06930317804333</basicUdiDi>
    <tradeName>06930317804333</tradeName>
    <deviceName>MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR)</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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-21</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:38.306Z</lastUpdated>
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  <row>
    <udiDi>06930317804326</udiDi>
    <basicUdiDi>B-06930317804326</basicUdiDi>
    <tradeName>06930317804326</tradeName>
    <deviceName>MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR)</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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-21</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:35.911Z</lastUpdated>
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  <row>
    <udiDi>06930317804319</udiDi>
    <basicUdiDi>B-06930317804319</basicUdiDi>
    <tradeName>06930317804319</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1411-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:34.277Z</lastUpdated>
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  <row>
    <udiDi>06930317802889</udiDi>
    <basicUdiDi>B-06930317802889</basicUdiDi>
    <tradeName>06930317802889</tradeName>
    <deviceName>Dynamiker SARS-CoV-2 Ag Rapid Test (POCT Chemiluminescence)</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-1901-57</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:33.863Z</lastUpdated>
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  <row>
    <udiDi>06930317802827</udiDi>
    <basicUdiDi>B-06930317802827</basicUdiDi>
    <tradeName>06930317802827</tradeName>
    <deviceName>Dynamiker SARS-CoV-2 Ag Rapid Test (POCT Chemiluminescence)</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-1901-57</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:29.492Z</lastUpdated>
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  <row>
    <udiDi>06930317802780</udiDi>
    <basicUdiDi>B-06930317802780</basicUdiDi>
    <tradeName>06930317802780</tradeName>
    <deviceName>Dynamiker Influenza B IgM Assay (Chemiluminescence)</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>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-52</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:23.086Z</lastUpdated>
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  <row>
    <udiDi>06930317802773</udiDi>
    <basicUdiDi>B-06930317802773</basicUdiDi>
    <tradeName>06930317802773</tradeName>
    <deviceName>Dynamiker Influenza B IgM Assay (Chemiluminescence)</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>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-52</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:39:21.488Z</lastUpdated>
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