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    <basicUdiDi>697721162HSCPVMM</basicUdiDi>
    <tradeName>06977211620195</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCA01-JA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:56.437Z</lastUpdated>
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    <udiDi>06977211620201</udiDi>
    <basicUdiDi>697721162HSSUPS</basicUdiDi>
    <tradeName>06977211620201</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCS-4A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:55.771Z</lastUpdated>
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    <udiDi>06977211620218</udiDi>
    <basicUdiDi>697721162HSDIMM</basicUdiDi>
    <tradeName>06977211620218</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDA01-MT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:54.044Z</lastUpdated>
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    <udiDi>06977211620225</udiDi>
    <basicUdiDi>697721162HSDTNB</basicUdiDi>
    <tradeName>06977211620225</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCD-5A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:52.900Z</lastUpdated>
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    <udiDi>06977211624506</udiDi>
    <basicUdiDi>697721162HSSUPS</basicUdiDi>
    <tradeName>06977211624506</tradeName>
    <deviceName>Slide Unit</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>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCS-4A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:22:39.511Z</lastUpdated>
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    <udiDi>06977211620065</udiDi>
    <basicUdiDi>697721162IWSISQH</basicUdiDi>
    <tradeName>06977211620065</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-05A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:22:38.386Z</lastUpdated>
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    <udiDi>06977211629006</udiDi>
    <basicUdiDi>697721162HSFASSPF</basicUdiDi>
    <tradeName>06977211629006</tradeName>
    <deviceName>Fully Automated Slide Sorter</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>W0202059099</emdnCode>
    <emdnDescription>VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FASS-1280A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:23.782Z</lastUpdated>
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    <udiDi>06977211628504</udiDi>
    <basicUdiDi>697721162HSATPSR2</basicUdiDi>
    <tradeName>06977211628504</tradeName>
    <deviceName>Automated Tissue Processing System</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>W0202059004</emdnCode>
    <emdnDescription>TISSUE EMBEDDING PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATP-96A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:22.168Z</lastUpdated>
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    <udiDi>06977211628009</udiDi>
    <basicUdiDi>697721162HSSFKNH</basicUdiDi>
    <tradeName>06977211628009</tradeName>
    <deviceName>Sputum Filter 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>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCP-5T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:21.364Z</lastUpdated>
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  <row>
    <udiDi>06977211627507</udiDi>
    <basicUdiDi>697721162HSPPSPG</basicUdiDi>
    <tradeName>06977211627507</tradeName>
    <deviceName>Pre-Processing Solution</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>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRA01-QT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:19.763Z</lastUpdated>
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  <row>
    <udiDi>06977211627002</udiDi>
    <basicUdiDi>697721162HSLSNZ</basicUdiDi>
    <tradeName>06977211627002</tradeName>
    <deviceName>Lysis Solution</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>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLA01-MT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:17.361Z</lastUpdated>
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  <row>
    <udiDi>06977211626500</udiDi>
    <basicUdiDi>697721162HSDTNB</basicUdiDi>
    <tradeName>06977211626500</tradeName>
    <deviceName>Disposable Tip</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>W0503020201</emdnCode>
    <emdnDescription>PIPETTE TIPS WITH FILTER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCD-5A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:15.760Z</lastUpdated>
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    <udiDi>06977211626005</udiDi>
    <basicUdiDi>697721162HSDIMM</basicUdiDi>
    <tradeName>06977211626005</tradeName>
    <deviceName>Diluent</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>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDA01-MT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:14.962Z</lastUpdated>
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    <udiDi>06977211625503</udiDi>
    <basicUdiDi>697721162HSCPSMF</basicUdiDi>
    <tradeName>06977211625503</tradeName>
    <deviceName>Cell Preservation Solution</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>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCA03-DT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:13.353Z</lastUpdated>
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    <udiDi>06977211625008</udiDi>
    <basicUdiDi>697721162HSBUN7</basicUdiDi>
    <tradeName>06977211625008</tradeName>
    <deviceName>Buffer</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>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FBA01-MT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:10.955Z</lastUpdated>
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    <udiDi>06977211623042</udiDi>
    <basicUdiDi>697721162HSLSPNX</basicUdiDi>
    <tradeName>Healtshsky</tradeName>
    <deviceName>Laser Slide Printer</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>W0202059017</emdnCode>
    <emdnDescription>CASSETTE / SLIDE PRINTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMarker-11A-S100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:09.360Z</lastUpdated>
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    <udiDi>06977211623004</udiDi>
    <basicUdiDi>697721162HSMHLCPZ8</basicUdiDi>
    <tradeName>Healtshsky</tradeName>
    <deviceName>Multi Hopper Laser Cassette Printer</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>W0202059017</emdnCode>
    <emdnDescription>CASSETTE / SLIDE PRINTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBMarker-160</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:08.562Z</lastUpdated>
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    <udiDi>06977211624001</udiDi>
    <basicUdiDi>697721162HSCPVMM</basicUdiDi>
    <tradeName>06977211624001</tradeName>
    <deviceName>Cell Preservation Vial</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>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCA01-JA</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:06.956Z</lastUpdated>
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    <udiDi>06977211622007</udiDi>
    <basicUdiDi>697721162HSPSKP9</basicUdiDi>
    <tradeName>Healthsky</tradeName>
    <deviceName>Papanicolaou Stain 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>W01030708</emdnCode>
    <emdnDescription>STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPA01-AT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:20:04.550Z</lastUpdated>
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    <udiDi>06977211621055</udiDi>
    <basicUdiDi>697721162HSELBCPKB2</basicUdiDi>
    <tradeName>Healthsky</tradeName>
    <deviceName>EASY-TLT 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>FGA01-1B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:19:49.296Z</lastUpdated>
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