<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971318440113</udiDi>
    <basicUdiDi>697131844001E88</basicUdiDi>
    <tradeName>VivoCardio</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Insight Lifetech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011205</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOVASCULAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U152301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:49:46.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971318441288</udiDi>
    <basicUdiDi>697131844002P8Z</basicUdiDi>
    <tradeName>06971318441288</tradeName>
    <deviceName>Pullback unit</deviceName>
    <manufacturerName>Insight Lifetech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011205</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:49:04.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971318440014</udiDi>
    <basicUdiDi>B-06971318440014</basicUdiDi>
    <tradeName>TruePhysio® Rapid Exchange Pressure Microcatheter</tradeName>
    <deviceName>TruePhysio® Rapid Exchange Pressure Microcatheter</deviceName>
    <manufacturerName>Insight Lifetech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011205</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104010101</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-14-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:24:11.288Z</lastUpdated>
  </row>
</eudamedExport>