<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09351351001163</udiDi>
    <basicUdiDi>B-09351351001163</basicUdiDi>
    <tradeName>Khelix Quadpolar Fixed Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Quadpolar Fixed Electrophysiology Catheter [5SSF-ANN-4A555]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010401</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5SSF-ANN-4A555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:59:16.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850298007096</udiDi>
    <basicUdiDi>0850298007099H</basicUdiDi>
    <tradeName>00850298007096</tradeName>
    <deviceName>Monitoring Lead Wires for EMG Monitoring 60" Leads Set of 2</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009421</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C02010401</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELDS-BR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:25.172Z</lastUpdated>
  </row>
</eudamedExport>