<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06976904310016</udiDi>
    <basicUdiDi>697690431hzpyswkjyxgs1UZ</basicUdiDi>
    <tradeName>STATSPEC</tradeName>
    <deviceName>Full Automatic Sample Processing System</deviceName>
    <manufacturerName>Huzhou Puyuan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038643</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MT-696</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:04:59.283Z</lastUpdated>
  </row>
</eudamedExport>