<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06953792720141</udiDi>
    <basicUdiDi>B-06953792720141</basicUdiDi>
    <tradeName>06953792720141</tradeName>
    <deviceName>HemoPOC Coagulometer</deviceName>
    <manufacturerName>Helixgen (GUANGZHOU) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034593</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02020602</emdnCode>
    <emdnDescription>RAPID TEST HEMOSTASIS INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HZ-200401</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:51:18.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06953792720134</udiDi>
    <basicUdiDi>B-06953792720134</basicUdiDi>
    <tradeName>06953792720134</tradeName>
    <deviceName>PT/INR test strip</deviceName>
    <manufacturerName>Helixgen (GUANGZHOU) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034593</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020801</emdnCode>
    <emdnDescription>PROTHROMBIN TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HZ-200124</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:51:17.596Z</lastUpdated>
  </row>
</eudamedExport>