<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05056080501543</udiDi>
    <basicUdiDi>50560805StapharexCardsBK</basicUdiDi>
    <tradeName>Staphaurex Disposable Reaction Cards (50 cards per pack)</tradeName>
    <deviceName>STAPHAUREX DISPOSABLE REACTION CARDS</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080399</emdnCode>
    <emdnDescription>IMMUNOLOGICAL IDENTIFICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30369001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:23:32.760Z</lastUpdated>
  </row>
</eudamedExport>