<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05056013025825</udiDi>
    <basicUdiDi>505601300ULTCEIDCG</basicUdiDi>
    <tradeName>UltraCE Immunodisplacement</tradeName>
    <deviceName>UltraCE Immunodisplacement</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010110</emdnCode>
    <emdnDescription>IMMUNOELECTROPHORESIS KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8140</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:31.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977738300006</udiDi>
    <basicUdiDi>B-06977738300006</basicUdiDi>
    <tradeName>06977738300006</tradeName>
    <deviceName>PLAU/SPP1/MMP1 Gene Detection Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Shanghai Focusgen Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000044043</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010110</emdnCode>
    <emdnDescription>IMMUNOELECTROPHORESIS KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:52.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977738300013</udiDi>
    <basicUdiDi>B-06977738300013</basicUdiDi>
    <tradeName>06977738300013</tradeName>
    <deviceName>PLAU/SPP1/MMP1 Gene Detection Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Shanghai Focusgen Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000044043</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010110</emdnCode>
    <emdnDescription>IMMUNOELECTROPHORESIS KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:50.218Z</lastUpdated>
  </row>
</eudamedExport>