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    <tradeName>KET Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.813Z</lastUpdated>
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    <basicUdiDi>B-06974473302531</basicUdiDi>
    <tradeName>H-FABP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-06974473302715</basicUdiDi>
    <tradeName>ALC Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.768Z</lastUpdated>
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    <udiDi>06974473302746</udiDi>
    <basicUdiDi>B-06974473302746</basicUdiDi>
    <tradeName>NT-proBNP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XJ012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>06974473302784</udiDi>
    <basicUdiDi>B-06974473302784</basicUdiDi>
    <tradeName>K2 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP026</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.730Z</lastUpdated>
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    <udiDi>06974473302951</udiDi>
    <basicUdiDi>B-06974473302951</basicUdiDi>
    <tradeName>APAP Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.703Z</lastUpdated>
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    <udiDi>06974473303064</udiDi>
    <basicUdiDi>B-06974473303064</basicUdiDi>
    <tradeName>Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.682Z</lastUpdated>
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    <udiDi>06974473303132</udiDi>
    <basicUdiDi>B-06974473303132</basicUdiDi>
    <tradeName>Typhoid Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.659Z</lastUpdated>
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    <udiDi>06974473303149</udiDi>
    <basicUdiDi>B-06974473303149</basicUdiDi>
    <tradeName>MTD Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.636Z</lastUpdated>
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    <udiDi>06974473303163</udiDi>
    <basicUdiDi>B-06974473303163</basicUdiDi>
    <tradeName>IGFBP-1 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YS009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.608Z</lastUpdated>
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    <udiDi>06974473303491</udiDi>
    <basicUdiDi>B-06974473303491</basicUdiDi>
    <tradeName>THC Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.577Z</lastUpdated>
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    <udiDi>06974473303712</udiDi>
    <basicUdiDi>697447330HC10HD</basicUdiDi>
    <tradeName>HC-10 Portable Colloidal Gold Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HC10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.532Z</lastUpdated>
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    <udiDi>06974473303774</udiDi>
    <basicUdiDi>B-06974473303774</basicUdiDi>
    <tradeName>Cervical Pre-cancer And Cancer Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.500Z</lastUpdated>
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    <udiDi>06974473303804</udiDi>
    <basicUdiDi>B-06974473303804</basicUdiDi>
    <tradeName>HSV 12 Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.469Z</lastUpdated>
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    <udiDi>06974473304047</udiDi>
    <basicUdiDi>B-06974473304047</basicUdiDi>
    <tradeName>Bacterial vaginosis Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.443Z</lastUpdated>
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    <udiDi>06974473304061</udiDi>
    <basicUdiDi>B-06974473304061</basicUdiDi>
    <tradeName>PCT/IL-6 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR042</reference>
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    <lastUpdated>2026-06-16T09:59:58.423Z</lastUpdated>
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    <basicUdiDi>B-06974473304207</basicUdiDi>
    <tradeName>AMP  Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP001</reference>
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    <lastUpdated>2026-06-16T09:59:58.410Z</lastUpdated>
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    <basicUdiDi>B-06974473304450</basicUdiDi>
    <tradeName>OXY Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP020</reference>
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    <lastUpdated>2026-06-16T09:59:58.393Z</lastUpdated>
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    <basicUdiDi>B-06974473304498</basicUdiDi>
    <tradeName>MOP Rapid Test Kit (Colloidal gold method)</tradeName>
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    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP002</reference>
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    <basicUdiDi>B-06974473304528</basicUdiDi>
    <tradeName>BZO Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:59:58.360Z</lastUpdated>
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