<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850008997006</udiDi>
    <basicUdiDi>0850008997CORDELLAXA</basicUdiDi>
    <tradeName>Cordella Sensor Delivery Kit (includes Cordella Sensor and Cordella Delivery System)</tradeName>
    <deviceName>Cordella Pulmonary Artery Sensor System</deviceName>
    <manufacturerName>Endotronix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000043257</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J010701</emdnCode>
    <emdnDescription>PULMONARY BLOOD PRESSURE REMOTE MONITORING SYSTEMS (INCLUDING SENSORS)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>100303-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T17:14:50.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008997013</udiDi>
    <basicUdiDi>0850008997CORDELLAXA</basicUdiDi>
    <tradeName>myCordella Handheld Patient Reader and Docking Station (includes myCordella Handheld Patient Reader and myCordella Docking Station)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Endotronix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000043257</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J010701</emdnCode>
    <emdnDescription>PULMONARY BLOOD PRESSURE REMOTE MONITORING SYSTEMS (INCLUDING SENSORS)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>100502-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T16:41:37.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008997136</udiDi>
    <basicUdiDi>0850008997CORDELLAXA</basicUdiDi>
    <tradeName>Cordella Pulmonary Artery Sensor System Calibration Equipment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Endotronix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000043257</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J010701</emdnCode>
    <emdnDescription>PULMONARY BLOOD PRESSURE REMOTE MONITORING SYSTEMS (INCLUDING SENSORS)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>100622-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T16:41:37.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008997051</udiDi>
    <basicUdiDi>0850008997CORDELLAXA</basicUdiDi>
    <tradeName>Cordella Data Analysis Platform (CDAP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Endotronix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000043257</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J010701</emdnCode>
    <emdnDescription>PULMONARY BLOOD PRESSURE REMOTE MONITORING SYSTEMS (INCLUDING SENSORS)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>100543-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T16:41:37.200Z</lastUpdated>
  </row>
</eudamedExport>