<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975614169044</udiDi>
    <basicUdiDi>697561416NAT1N7</basicUdiDi>
    <tradeName>06975614169044</tradeName>
    <deviceName>Fully-Automated Nucleic Acid Amplification Testing System</deviceName>
    <manufacturerName>Genewise Bio Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038313</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NAT-3000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:24:15.068Z</lastUpdated>
  </row>
</eudamedExport>