<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>01240000008708</udiDi>
    <basicUdiDi>12400000087NIPTA6S</basicUdiDi>
    <tradeName>iSAFETM NIPT Kit with 6-color naica system:</tradeName>
    <deviceName>iSAFETM NIPT Kit with naica 6-color system</deviceName>
    <manufacturerName>Atila Biosystems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023011</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIPT-100AS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:16:42.939Z</lastUpdated>
  </row>
</eudamedExport>