<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>00857595006432</udiDi>
    <basicUdiDi>B-00857595006432</basicUdiDi>
    <tradeName>Makoto Intravascular Imaging System™</tradeName>
    <deviceName>Makoto Intravascular Imaging System™</deviceName>
    <manufacturerName>Nipro Vascular Innovations Americas, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002341</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019004</emdnCode>
    <emdnDescription>CARDIOVASCULAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TVC-MC10</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:47.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857595006234</udiDi>
    <basicUdiDi>B-00857595006234</basicUdiDi>
    <tradeName>Dualpro™ IVUS+NIRS Imaging Catheter</tradeName>
    <deviceName>Dualpro™ IVUS+NIRS Imaging Catheter</deviceName>
    <manufacturerName>Nipro Vascular Innovations Americas, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002341</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104010102</emdnCode>
    <emdnDescription>CARDIAC AND INTRACORONARY ULTRASOUND CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TVC-C195-42</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:43.390Z</lastUpdated>
  </row>
</eudamedExport>