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<eudamedExport entity="devices">
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    <udiDi>06978115480236</udiDi>
    <basicUdiDi>697811548HYKJ003ZM</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30ml/bottle</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:41:25.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480267</udiDi>
    <basicUdiDi>697811548HYKJ005ZR</basicUdiDi>
    <tradeName>HuayueKeju</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>2026-09-22T00:40:27.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480571</udiDi>
    <basicUdiDi>697811548HYKJ006ZT</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYKJLCT-24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:40:25.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480007</udiDi>
    <basicUdiDi>697811548HYKJ001ZH</basicUdiDi>
    <tradeName>HuayueKeju</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>450ml/bottle</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:23:55.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480021</udiDi>
    <basicUdiDi>697811548HYKJ002ZK</basicUdiDi>
    <tradeName>HuayueKeju</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>2026-09-22T00:23:33.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480106</udiDi>
    <basicUdiDi>697811548HYKJ003ZM</basicUdiDi>
    <tradeName>HuayueKeju</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>10ml/bottle</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:23:20.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480250</udiDi>
    <basicUdiDi>697811548HYKJ004ZP</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500ml/bottle</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:23:18.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480243</udiDi>
    <basicUdiDi>697811548HYKJ004ZP</basicUdiDi>
    <tradeName>HuayueKeju</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>450ml/bottle</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:23:14.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480588</udiDi>
    <basicUdiDi>697811548HYKJ006ZT</basicUdiDi>
    <tradeName>HuayueKeju</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>2026-09-22T00:23:14.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480595</udiDi>
    <basicUdiDi>697811548HYKJ006ZT</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYKJLCT-72</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:23:13.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480601</udiDi>
    <basicUdiDi>697811548HYKJ006ZT</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYKJTCT-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:23:13.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480656</udiDi>
    <basicUdiDi>697811548HYKJ007ZV</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E: Disposable production cabin, 200 pieces/pack;</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:22:59.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480663</udiDi>
    <basicUdiDi>697811548HYKJ007ZV</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F: Disposable filter, 200 pieces/pack;</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:22:59.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480618</udiDi>
    <basicUdiDi>697811548HYKJ007ZV</basicUdiDi>
    <tradeName>HuayueKeju</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>2026-09-22T00:22:58.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480687</udiDi>
    <basicUdiDi>697811548HYKJ007ZV</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H: Adhesive glass slides, 50 pieces/box;</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:22:58.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480625</udiDi>
    <basicUdiDi>697811548HYKJ007ZV</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B: Disposable straw 3ml, 100 tubes/pack;</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:22:58.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480632</udiDi>
    <basicUdiDi>697811548HYKJ007ZV</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C: Disposable centrifuge tube (10ml), 200 tubes/pack;</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:22:58.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480649</udiDi>
    <basicUdiDi>697811548HYKJ007ZV</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D: Disposable centrifuge tube 50ml, 50 pieces/pack;</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:22:57.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978115480670</udiDi>
    <basicUdiDi>697811548HYKJ007ZV</basicUdiDi>
    <tradeName>HuayueKeju</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 pieces/box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:45:02.631Z</lastUpdated>
  </row>
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