<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598002272</udiDi>
    <basicUdiDi>B-04050598002272</basicUdiDi>
    <tradeName>MutaPLEX® GBS (Group B Streptococci), PCR</tradeName>
    <deviceName>MutaPLEX® GBS (Group B Streptococci), PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011102</emdnCode>
    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG191096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:10.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973492240183</udiDi>
    <basicUdiDi>697349224U2030112C000EU</basicUdiDi>
    <tradeName>EasyNAT GBS Assay</tradeName>
    <deviceName>EasyNAT GBS Assay</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011102</emdnCode>
    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U20311</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:04:30.430Z</lastUpdated>
  </row>
</eudamedExport>