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    <basicUdiDi>B-06930317887145</basicUdiDi>
    <tradeName>06930317887145</tradeName>
    <deviceName>Dynamiker Aspergillus fumigatus IgG 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>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-60</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:41.433Z</lastUpdated>
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    <udiDi>06930317886568</udiDi>
    <basicUdiDi>B-06930317886568</basicUdiDi>
    <tradeName>06930317886568</tradeName>
    <deviceName>Dynamiker Aspergillus fumigatus IgG 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>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-60</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:37.432Z</lastUpdated>
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    <udiDi>06930317883345</udiDi>
    <basicUdiDi>B-06930317883345</basicUdiDi>
    <tradeName>06930317883345</tradeName>
    <deviceName>Dynamiker Influenza B 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-1901-56</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:37.077Z</lastUpdated>
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    <udiDi>06930317880399</udiDi>
    <basicUdiDi>B-06930317880399</basicUdiDi>
    <tradeName>06930317880399</tradeName>
    <deviceName>Dynamiker Adenovirus Antigen Test Kit (LFA)</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>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2506-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:35.828Z</lastUpdated>
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    <udiDi>06930317874770</udiDi>
    <basicUdiDi>B-06930317874770</basicUdiDi>
    <tradeName>06930317874770</tradeName>
    <deviceName>Human Metapneumovirus antigen test kit (LFA)</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>W0105040617</emdnCode>
    <emdnDescription>HUMAN METAPNEUMOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2505-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:35.018Z</lastUpdated>
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    <udiDi>06930317873414</udiDi>
    <basicUdiDi>B-06930317873414</basicUdiDi>
    <tradeName>06930317873414</tradeName>
    <deviceName>Dynamiker Cryptococcus neoformans 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>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-62</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:31.008Z</lastUpdated>
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    <udiDi>06930317871496</udiDi>
    <basicUdiDi>B-06930317871496</basicUdiDi>
    <tradeName>06930317871496</tradeName>
    <deviceName>Helicobacter pylori IgG antibody test kit (LFA)</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>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2503-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:30.205Z</lastUpdated>
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    <udiDi>06930317870284</udiDi>
    <basicUdiDi>B-06930317870284</basicUdiDi>
    <tradeName>06930317870284</tradeName>
    <deviceName>Dynamiker Cryptococcus neoformans 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>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-62</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:29.585Z</lastUpdated>
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  <row>
    <udiDi>06930317870048</udiDi>
    <basicUdiDi>B-06930317870048</basicUdiDi>
    <tradeName>06930317870048</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>2026-08-03T09:41:28.629Z</lastUpdated>
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  <row>
    <udiDi>06930317865518</udiDi>
    <basicUdiDi>B-06930317865518</basicUdiDi>
    <tradeName>06930317865518</tradeName>
    <deviceName>Dynamiker Cryptococcus neoformans 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>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-62</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:23.826Z</lastUpdated>
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  <row>
    <udiDi>06930317864771</udiDi>
    <basicUdiDi>B-06930317864771</basicUdiDi>
    <tradeName>06930317864771</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2401-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:23.078Z</lastUpdated>
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  <row>
    <udiDi>06930317861619</udiDi>
    <basicUdiDi>B-06930317861619</basicUdiDi>
    <tradeName>06930317861619</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>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:22.220Z</lastUpdated>
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    <udiDi>06930317858251</udiDi>
    <basicUdiDi>B-06930317858251</basicUdiDi>
    <tradeName>06930317858251</tradeName>
    <deviceName>Dynamiker HRV / HMPV / MP / ADV Antigens Combo Test Kit（LFA）</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>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2509-1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:17.423Z</lastUpdated>
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  <row>
    <udiDi>06930317857865</udiDi>
    <basicUdiDi>B-06930317857865</basicUdiDi>
    <tradeName>06930317857865</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2401-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:16.754Z</lastUpdated>
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    <udiDi>06930317855410</udiDi>
    <basicUdiDi>B-06930317855410</basicUdiDi>
    <tradeName>06930317855410</tradeName>
    <deviceName>Dynamiker Fungus (1-3)-β-D-Glucan 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>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-63</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:15.797Z</lastUpdated>
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    <udiDi>06930317853195</udiDi>
    <basicUdiDi>B-06930317853195</basicUdiDi>
    <tradeName>06930317853195</tradeName>
    <deviceName>Carbapenem Resistant Enterobacteriaceae Test Kit (LFA)</deviceName>
    <manufacturerName>Dynamiker Biotechnology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001133</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-2302-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:12.194Z</lastUpdated>
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    <udiDi>06930317848719</udiDi>
    <basicUdiDi>B-06930317848719</basicUdiDi>
    <tradeName>06930317848719</tradeName>
    <deviceName>Dynamiker Aspergillus fumigatus IgG 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>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-60</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:41:12.045Z</lastUpdated>
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    <udiDi>06930317845107</udiDi>
    <basicUdiDi>B-06930317845107</basicUdiDi>
    <tradeName>06930317845107</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>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-59</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:40:58.896Z</lastUpdated>
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    <udiDi>06930317843561</udiDi>
    <basicUdiDi>B-06930317843561</basicUdiDi>
    <tradeName>06930317843561</tradeName>
    <deviceName>Dynamiker Fungus (1-3)-β-D-Glucan 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>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNK-1901-63</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:40:55.115Z</lastUpdated>
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    <udiDi>06930317842236</udiDi>
    <basicUdiDi>B-06930317842236</basicUdiDi>
    <tradeName>06930317842236</tradeName>
    <deviceName>Dynamiker Candida albicans IgG 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-1901-61</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:40:54.134Z</lastUpdated>
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