<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970293020716</udiDi>
    <basicUdiDi>697029302dye00177</basicUdiDi>
    <tradeName>06970293020716</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>06970293020716</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:49.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020693</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020693</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>06970293020693</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:48.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020686</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020686</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>06970293020686</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:47.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020679</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020679</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>06970293020679</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:46.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020662</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020662</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>06970293020662</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:38.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020655</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293020655</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>06970293020655</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:37.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020624</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020624</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>06970293020624</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:36.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020617</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020617</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>06970293020617</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:35.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020600</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020600</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>06970293020600</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:27.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020594</udiDi>
    <basicUdiDi>697029302diluent001DG</basicUdiDi>
    <tradeName>06970293020594</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>06970293020594</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:26.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020587</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020587</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>06970293020587</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:25.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020570</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293020570</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>06970293020570</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:24.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020563</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020563</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>06970293020563</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:18.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020556</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293020556</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>06970293020556</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:17.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020549</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293020549</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>06970293020549</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:16.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020532</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293020532</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>06970293020532</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:13.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020525</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020525</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>06970293020525</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:07.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020518</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293020518</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>06970293020518</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:06.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020501</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293020501</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>06970293020501</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:05.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970293020495</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293020495</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>06970293020495</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:48:03.956Z</lastUpdated>
  </row>
</eudamedExport>