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<eudamedExport entity="devices">
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    <basicUdiDi>B-USMF000014219000034QM</basicUdiDi>
    <tradeName>THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020301</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D131501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:42.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014219000033QK</udiDi>
    <basicUdiDi>B-USMF000014219000033QK</basicUdiDi>
    <tradeName>THERMOCOOL SF BI-DIRECTIONAL CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020301</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BDI35DJRT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:42.563Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000014219000032QH</udiDi>
    <basicUdiDi>B-USMF000014219000032QH</basicUdiDi>
    <tradeName>THERMOCOOL SF BI-DIRECTIONAL CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020301</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BDI35BFRT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:41.384Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000014219000031QF</udiDi>
    <basicUdiDi>B-USMF000014219000031QF</basicUdiDi>
    <tradeName>THERMOCOOL SF BI-DIRECTIONAL CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020301</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BDI35BBRT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:37.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014219000030QD</udiDi>
    <basicUdiDi>B-USMF000014219000030QD</basicUdiDi>
    <tradeName>THERMOCOOL SF BI-DIRECTIONAL CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020301</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BDI35JJRT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:36.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014219000029QU</udiDi>
    <basicUdiDi>B-USMF000014219000029QU</basicUdiDi>
    <tradeName>THERMOCOOL SF BI-DIRECTIONAL CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020301</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BDI35FFRT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:35.465Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000014219000028QS</udiDi>
    <basicUdiDi>B-USMF000014219000028QS</basicUdiDi>
    <tradeName>THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020301</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BNI35DFCT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:34.659Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000014219000027QQ</udiDi>
    <basicUdiDi>B-USMF000014219000027QQ</basicUdiDi>
    <tradeName>THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020301</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BNI35FJCT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:30.937Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000014219000001Q6</udiDi>
    <basicUdiDi>B-USMF000014219000001Q6</basicUdiDi>
    <tradeName>HELIOSTAR Balloon Ablation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020301</emdnCode>
    <emdnDescription>ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D138904</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:37:35.974Z</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>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T20:58:17.610Z</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>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M409</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T20:58:17.563Z</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>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M410</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T20:58:17.510Z</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>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M411</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T20:58:12.496Z</lastUpdated>
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  <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>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M412</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T20:58:12.441Z</lastUpdated>
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    <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>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T20:58:12.391Z</lastUpdated>
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    <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>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M415</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T20:58:12.320Z</lastUpdated>
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    <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>
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    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M416</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T20:58:12.248Z</lastUpdated>
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    <udiDi>00810087180287</udiDi>
    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
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    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M417</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T20:58:12.186Z</lastUpdated>
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    <udiDi>D-109-0014-023SW</udiDi>
    <basicUdiDi>B-109-0014-023SW</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-023</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:40.270Z</lastUpdated>
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    <udiDi>D-109-0014-022SU</udiDi>
    <basicUdiDi>B-109-0014-022SU</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-022</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:37.820Z</lastUpdated>
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