<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06978380060003</udiDi>
    <basicUdiDi>697838006CHMINIPCRYM</basicUdiDi>
    <tradeName>06978380060003</tradeName>
    <deviceName>Mini PCR</deviceName>
    <manufacturerName>Suzhou Changhe Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045901</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HTM-8T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:29:34.763Z</lastUpdated>
  </row>
</eudamedExport>