<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970293022321</udiDi>
    <basicUdiDi>697029302diluent001DG</basicUdiDi>
    <tradeName>06970293022321</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>06970293022321</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:30.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022314</udiDi>
    <basicUdiDi>697029302diluent001DG</basicUdiDi>
    <tradeName>06970293022314</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>06970293022314</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:29.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022307</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022307</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>'06970293022307</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:28.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022291</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293022291</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>06970293022291</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:27.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022284</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022284</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>06970293022284</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:21.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022277</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022277</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>06970293022277</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:19.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022260</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293022260</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>06970293022260</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:18.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022253</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022253</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>06970293022253</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:17.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022246</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293022246</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>06970293022246</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:11.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022239</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293022239</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>06970293022239</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:10.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022222</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022222</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>06970293022222</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:09.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022215</udiDi>
    <basicUdiDi>697029302dye00177</basicUdiDi>
    <tradeName>06970293022215</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>06970293022215</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:07.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022208</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022208</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>06970293022208</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:01.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022192</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022192</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>06970293022192</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:54:00.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022185</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293022185</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>06970293022185</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:53:59.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022178</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022178</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>06970293022178</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:53:58.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022161</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022161</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>06970293022161</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:53:52.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022154</udiDi>
    <basicUdiDi>697029302dye00177</basicUdiDi>
    <tradeName>06970293022154</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>06970293022154</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:53:50.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022147</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293022147</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>06970293022147</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:53:49.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293022130</udiDi>
    <basicUdiDi>697029302dye00177</basicUdiDi>
    <tradeName>06970293022130</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>06970293022130</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:53:48.584Z</lastUpdated>
  </row>
</eudamedExport>