<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00866379000122</udiDi>
    <basicUdiDi>B-00866379000122</basicUdiDi>
    <tradeName>RenalGuard Console</tradeName>
    <deviceName>RenalGuard Console</deviceName>
    <manufacturerName>CardioRenal Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035063</manufacturerSrn>
    <authorisedRepresentativeName>RenalGuard Solutions EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000020280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03010105</emdnCode>
    <emdnDescription>INFUSION PUMP CONTROLLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:46.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866379000108</udiDi>
    <basicUdiDi>B-00866379000108</basicUdiDi>
    <tradeName>RenalGuard Single Use Set</tradeName>
    <deviceName>RenalGuard Single Use Set</deviceName>
    <manufacturerName>CardioRenal Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035063</manufacturerSrn>
    <authorisedRepresentativeName>RenalGuard Solutions EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000020280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A99</emdnCode>
    <emdnDescription>DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC00050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:43.911Z</lastUpdated>
  </row>
</eudamedExport>