<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10841716103572</udiDi>
    <basicUdiDi>B-10841716103572</basicUdiDi>
    <tradeName>RXi System dPR</tradeName>
    <deviceName>Rapid Exchange (RXi) System, dPR</deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010403</emdnCode>
    <emdnDescription>FRACTIONAL FLOW RESERVE (FFR) MEASUREMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>016616</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T14:50:30.864Z</lastUpdated>
  </row>
</eudamedExport>