<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06935771608411</udiDi>
    <basicUdiDi>6935771608411BB</basicUdiDi>
    <tradeName>SERODIA®-TP·PA</tradeName>
    <deviceName>Passive Particle Agglutination Test for Detection of Antibodies to Treponema Pallidum</deviceName>
    <manufacturerName>Zhuhai Livzon Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000053720</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A00201100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:37.799Z</lastUpdated>
  </row>
</eudamedExport>