<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810087180119</udiDi>
    <basicUdiDi>B-00810087180119</basicUdiDi>
    <tradeName>FARASTAR</tradeName>
    <deviceName>FARASTAR Catheter Connection Cable</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020304</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41M404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:39:23.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180102</udiDi>
    <basicUdiDi>B-00810087180102</basicUdiDi>
    <tradeName>FARAWAVE™</tradeName>
    <deviceName>FARAWAVE Pulsed Field Ablation Catheter, 35mm</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020304</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41M402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:39:22.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180096</udiDi>
    <basicUdiDi>B-00810087180096</basicUdiDi>
    <tradeName>FARAWAVE™</tradeName>
    <deviceName>FARAWAVE Pulsed Field Ablation Catheter, 31mm</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020304</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41M401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:39:21.058Z</lastUpdated>
  </row>
</eudamedExport>