<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00815845024100</udiDi>
    <basicUdiDi>B-00815845024100</basicUdiDi>
    <tradeName>SureStep CE</tradeName>
    <deviceName>SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup</deviceName>
    <manufacturerName>Innovacon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057104</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBO-167-261</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T14:10:42.849Z</lastUpdated>
  </row>
</eudamedExport>