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    <basicUdiDi>697811548HYKJ007ZV</basicUdiDi>
    <tradeName>06978115480618</tradeName>
    <deviceName>Liquid-based cytology slide processor  consumables set</deviceName>
    <manufacturerName>Guangzhou Huayue Keju Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057705</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>A: Disposable suction nozzle (5ml), 200 pieces/pack</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:02:26.465Z</lastUpdated>
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    <udiDi>06978115480588</udiDi>
    <basicUdiDi>697811548HYKJ006ZT</basicUdiDi>
    <tradeName>06978115480588</tradeName>
    <deviceName>Liquid-based cytology slide processor</deviceName>
    <manufacturerName>Guangzhou Huayue Keju Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057705</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>HYKJLCT-48</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:02:25.658Z</lastUpdated>
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    <udiDi>06978115480267</udiDi>
    <basicUdiDi>697811548HYKJ005ZR</basicUdiDi>
    <tradeName>06978115480267</tradeName>
    <deviceName>Sample Release Reagent</deviceName>
    <manufacturerName>Guangzhou Huayue Keju Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057705</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A solution: 400ml/bottle X 1bottle</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:02:24.870Z</lastUpdated>
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    <udiDi>06978115480243</udiDi>
    <basicUdiDi>697811548HYKJ004ZP</basicUdiDi>
    <tradeName>06978115480243</tradeName>
    <deviceName>Sample density separation solution</deviceName>
    <manufacturerName>Guangzhou Huayue Keju Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057705</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010499</emdnCode>
    <emdnDescription>MICROBIOLOGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2 bottles/box：450ml / bottle</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:55:13.684Z</lastUpdated>
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    <udiDi>06978115480106</udiDi>
    <basicUdiDi>697811548HYKJ003ZM</basicUdiDi>
    <tradeName>06978115480106</tradeName>
    <deviceName>Cell preservation solution</deviceName>
    <manufacturerName>Guangzhou Huayue Keju Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057705</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>200 tests/box：10ml/bottle</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:55:12.881Z</lastUpdated>
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    <udiDi>06978115480021</udiDi>
    <basicUdiDi>697811548HYKJ002ZK</basicUdiDi>
    <tradeName>06978115480021</tradeName>
    <deviceName>Papanicolaou staining solution</deviceName>
    <manufacturerName>Guangzhou Huayue Keju Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057705</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>BS-450</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:55:12.076Z</lastUpdated>
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    <udiDi>06978115480007</udiDi>
    <basicUdiDi>697811548HYKJ001ZH</basicUdiDi>
    <tradeName>06978115480007</tradeName>
    <deviceName>Buffer solution</deviceName>
    <manufacturerName>Guangzhou Huayue Keju Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057705</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010805</emdnCode>
    <emdnDescription>BUFFERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4 bottles/box：450ml/bottle</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:55:11.276Z</lastUpdated>
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