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<eudamedExport entity="devices">
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    <basicUdiDi>B-00810087180126</basicUdiDi>
    <tradeName>FARASTAR</tradeName>
    <deviceName>FARASTAR Pulsed Field Ablation Generator</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120101</emdnCode>
    <emdnDescription>ARTERIOTOMY ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:40.637Z</lastUpdated>
  </row>
  <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>2026-07-04T16:02:39.818Z</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>2026-07-04T16:02:39.015Z</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>2026-07-04T16:02:38.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180072</udiDi>
    <basicUdiDi>B-00810087180072</basicUdiDi>
    <tradeName>FARADRIVE™</tradeName>
    <deviceName>FARADRIVE Steerable Sheath (clear)</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>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21M402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:22.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180133</udiDi>
    <basicUdiDi>081008718FARAGYE</basicUdiDi>
    <tradeName>FARASTAR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:19.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180171</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:19.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180188</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:19.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180218</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:19.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180225</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:19.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180232</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:19.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180249</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:19.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180256</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:19.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180263</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:18.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180270</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:18.924Z</lastUpdated>
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  <row>
    <udiDi>00810087180287</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-11T04:29:18.862Z</lastUpdated>
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  <row>
    <udiDi>00810087181321</udiDi>
    <basicUdiDi>081008718FARAGYE</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T09:16:05.408Z</lastUpdated>
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  <row>
    <udiDi>00810087181314</udiDi>
    <basicUdiDi>081008718FARAGYE</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T09:16:04.304Z</lastUpdated>
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</eudamedExport>