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    <tradeName>Healthsky</tradeName>
    <deviceName>Liquid-Based Cytology Processing Kit</deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</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>FGA01-1AP</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:19:48.503Z</lastUpdated>
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    <basicUdiDi>697721162HSDCSLD</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069085</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-MAR</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:19:47.715Z</lastUpdated>
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    <udiDi>06977211620010</udiDi>
    <basicUdiDi>697721162HSLBCSPXN</basicUdiDi>
    <tradeName>EASY-TLT</tradeName>
    <deviceName>Liquid-Based Cytology Slide Processor</deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-200</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:19:46.899Z</lastUpdated>
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    <udiDi>06977211620003</udiDi>
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    <tradeName>Healtshsky</tradeName>
    <deviceName>Fully Automated Liquid-Based Cytology Workstation</deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCTE-3600A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:19:42.901Z</lastUpdated>
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    <udiDi>06977211620034</udiDi>
    <basicUdiDi>697721162HSDCSLD</basicUdiDi>
    <tradeName>06977211620034</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069085</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-MIR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:59.140Z</lastUpdated>
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    <udiDi>06977211620041</udiDi>
    <basicUdiDi>697721162HSDCSLD</basicUdiDi>
    <tradeName>06977211620041</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069085</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-LIN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:59.121Z</lastUpdated>
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    <udiDi>06977211620072</udiDi>
    <basicUdiDi>697721162HSFALBCW98</basicUdiDi>
    <tradeName>06977211620072</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCTE-3600AP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:59.052Z</lastUpdated>
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    <udiDi>06977211620089</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620089</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-05B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:59.027Z</lastUpdated>
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    <udiDi>06977211620096</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620096</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-80A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:59.002Z</lastUpdated>
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    <udiDi>06977211620102</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620102</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-80B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.980Z</lastUpdated>
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    <udiDi>06977211620119</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620119</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-120A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.954Z</lastUpdated>
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    <udiDi>06977211620126</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620126</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-120B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.931Z</lastUpdated>
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    <udiDi>06977211620133</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620133</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-160A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.907Z</lastUpdated>
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    <udiDi>06977211620140</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620140</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-160B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.880Z</lastUpdated>
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    <udiDi>06977211620157</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620157</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-320A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.859Z</lastUpdated>
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    <udiDi>06977211620164</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620164</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-320B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.837Z</lastUpdated>
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    <udiDi>06977211620171</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
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    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-480A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.813Z</lastUpdated>
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    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>W0202050301</emdnCode>
    <emdnDescription>ELECTRON MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS-480B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.790Z</lastUpdated>
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    <basicUdiDi>697721162HSLBCPKX3</basicUdiDi>
    <tradeName>Healthsky</tradeName>
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    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</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>FGA01-1A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.762Z</lastUpdated>
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    <basicUdiDi>697721162HSLBCPKX3</basicUdiDi>
    <tradeName>Healthsky</tradeName>
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    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</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>FSA01-2A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:58.738Z</lastUpdated>
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