<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970293020488</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020488</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020488</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:56.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020471</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020471</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020471</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:55.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020464</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293020464</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020464</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:53.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020457</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293020457</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020457</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:51.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020112</udiDi>
    <basicUdiDi>697029302diluent001DG</basicUdiDi>
    <tradeName>06970293020112</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS DILUENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020112</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:45.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020440</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293020440</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020440</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:44.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020433</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020433</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020433</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:43.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020426</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293020426</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020426</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:42.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020419</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020419</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020419</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:36.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020396</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020396</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020396</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:35.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020389</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020389</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020389</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:33.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020341</udiDi>
    <basicUdiDi>697029302diluent001DG</basicUdiDi>
    <tradeName>06970293020341</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS DILUENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020341</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:29.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020365</udiDi>
    <basicUdiDi>697029302dye00177</basicUdiDi>
    <tradeName>06970293020365</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS STANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020365</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:29.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020228</udiDi>
    <basicUdiDi>697029302diluent001DG</basicUdiDi>
    <tradeName>06970293020228</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS DILUENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020228</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:26.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020327</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293020327</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020327</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:23.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020334</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020334</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020334</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:22.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020204</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293020204</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020204</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:20.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020310</udiDi>
    <basicUdiDi>697029302diluent001DG</basicUdiDi>
    <tradeName>06970293020310</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS DILUENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020310</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:16.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020303</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020303</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020303</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:14.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020297</udiDi>
    <basicUdiDi>697029302diluent001DG</basicUdiDi>
    <tradeName>06970293020297</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS DILUENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>06970293020297</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:11.894Z</lastUpdated>
  </row>
</eudamedExport>