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    <tradeName>VanGenes</tradeName>
    <deviceName>Vacuum Blood Collection System</deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 ml (Ordinary type)    ZXDNA1001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:20:26.057Z</lastUpdated>
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    <tradeName>06975516220072</tradeName>
    <deviceName>Universal DNA Library Prep Kit</deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZD101-01(24rxns)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:13:42.216Z</lastUpdated>
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    <tradeName>06975516220041</tradeName>
    <deviceName>MagPure Circulating DNA Kit</deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZEC601（480rxns）</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:13:41.414Z</lastUpdated>
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    <udiDi>16975516220017</udiDi>
    <basicUdiDi>697551622CFDNA100501Z9</basicUdiDi>
    <tradeName>VanGenes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 ml (Ordinary type)  ZXDNA0501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:50:54.791Z</lastUpdated>
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    <udiDi>16975516220024</udiDi>
    <basicUdiDi>697551622CFDNA100501Z9</basicUdiDi>
    <tradeName>VanGenes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 ml (Ordinary type)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:50:54.760Z</lastUpdated>
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    <udiDi>16975516220031</udiDi>
    <basicUdiDi>697551622CFDNA100501Z9</basicUdiDi>
    <tradeName>VanGenes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 ml (Ordinary type)   ZXDNA0501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:50:54.713Z</lastUpdated>
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    <tradeName>06975516220058</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZEC601-T48(96rxns)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:25.461Z</lastUpdated>
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    <basicUdiDi>697551622ZXMCDK2B</basicUdiDi>
    <tradeName>06975516220065</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZEC601-T96(96rxns)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:25.452Z</lastUpdated>
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    <udiDi>06975516220089</udiDi>
    <basicUdiDi>697551622ZXUDLPKJ9</basicUdiDi>
    <tradeName>06975516220089</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZD101-02(96rxns)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:25.433Z</lastUpdated>
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    <udiDi>06975516220096</udiDi>
    <basicUdiDi>697551622ZXUDLPKJ9</basicUdiDi>
    <tradeName>06975516220096</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZDM101-01(24rxns)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:25.424Z</lastUpdated>
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    <basicUdiDi>697551622ZXUDLPKJ9</basicUdiDi>
    <tradeName>06975516220102</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZDM101-02(96rxns)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:25.415Z</lastUpdated>
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