<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850001088015</udiDi>
    <basicUdiDi>B-00850001088015</basicUdiDi>
    <tradeName>00850001088015</tradeName>
    <deviceName>suiteHEART Software</deviceName>
    <manufacturerName>NeoSoft LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007437</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11050192</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NS-02-046-0009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:34:33.521Z</lastUpdated>
  </row>
</eudamedExport>