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    <tradeName>Rhythmia HDx™</tradeName>
    <deviceName>Rhythmia HDx Patch Kit</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020199</emdnCode>
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    <reference>M004RAPATCH20</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:54:48.334Z</lastUpdated>
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    <deviceName>Vektor Computational ECG Mapping System (vMap)</deviceName>
    <manufacturerName>Vektor Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047086</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-07-15T19:39:04.134Z</lastUpdated>
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    <udiDi>M58800101480010</udiDi>
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    <tradeName>SynX</tradeName>
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    <manufacturerName>Stereotaxis, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026621</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-014800-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:59:36.817Z</lastUpdated>
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    <udiDi>M58800101070010</udiDi>
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    <tradeName>Synchrony</tradeName>
    <deviceName>Synchrony System</deviceName>
    <manufacturerName>Stereotaxis, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026621</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-010700-1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:59:36.024Z</lastUpdated>
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    <udiDi>M58802000780040</udiDi>
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    <tradeName>Odyssey Cinema</tradeName>
    <deviceName>Odyssey Cinema</deviceName>
    <manufacturerName>Stereotaxis, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026621</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020-007800-4</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:59:34.412Z</lastUpdated>
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    <udiDi>M58800100701020</udiDi>
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    <tradeName>Odyssey Vision</tradeName>
    <deviceName>Odyssey Quad HD Vision</deviceName>
    <manufacturerName>Stereotaxis, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026621</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-007010-2</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:59:15.932Z</lastUpdated>
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    <udiDi>B938AFR000130</udiDi>
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    <deviceName>System Cart</deviceName>
    <manufacturerName>Affera, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018093</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <emdnCode>C020180</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR-00013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:02:36.188Z</lastUpdated>
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    <udiDi>B938AFR000070</udiDi>
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    <deviceName>Location Reference Patch Kit</deviceName>
    <manufacturerName>Affera, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018093</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020180</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR-00007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:02:35.391Z</lastUpdated>
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    <udiDi>B938AFR000060</udiDi>
    <basicUdiDi>++B938SPH9EXTCABLEK7</basicUdiDi>
    <tradeName>B938AFR000060</tradeName>
    <deviceName>Catheter Extension Cable</deviceName>
    <manufacturerName>Affera, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018093</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020180</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR-00006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:02:33.789Z</lastUpdated>
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  <row>
    <udiDi>B938AFR000030</udiDi>
    <basicUdiDi>++B938PRISM1HEXAMAPSYSHB</basicUdiDi>
    <tradeName>Prism-1 Mapping System</tradeName>
    <deviceName>Prism-1 Mapping System</deviceName>
    <manufacturerName>Affera, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018093</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR-00003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:02:31.400Z</lastUpdated>
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    <udiDi>D-USMF000014219000043QN</udiDi>
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    <tradeName>MYOSTAR INJECTION 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>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>121120S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:56.269Z</lastUpdated>
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    <udiDi>D-USMF000014219000042QL</udiDi>
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    <tradeName>MYOSTAR INJECTION 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>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>121119S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:55.490Z</lastUpdated>
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    <tradeName>LASSOSTAR Circular Mapping 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>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D139003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:29.867Z</lastUpdated>
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    <udiDi>D-USMF000014219000024QJ</udiDi>
    <basicUdiDi>B-USMF000014219000024QJ</basicUdiDi>
    <tradeName>LASSOSTAR Circular Mapping 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>
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    <legislation>MDD</legislation>
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    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D139001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:29.048Z</lastUpdated>
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    <udiDi>D-USMF000014219000025QL</udiDi>
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    <tradeName>LASSOSTAR Circular Mapping Catheter</tradeName>
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    <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>
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    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D139002</reference>
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    <lastUpdated>2026-07-15T08:38:28.265Z</lastUpdated>
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    <udiDi>D-USMF000014219000021QC</udiDi>
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    <tradeName>WEBSTER ELECTROPHYSIOLOGY CATHETER</tradeName>
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    <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>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37T03R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:24.252Z</lastUpdated>
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    <tradeName>NOGASTAR CARDIOLOGY CATHETER</tradeName>
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    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
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    <emdnCode>C020105</emdnCode>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>120708S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:23.988Z</lastUpdated>
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    <tradeName>NOGASTAR CARDIOLOGY CATHETER</tradeName>
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    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
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    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>C020105</emdnCode>
    <emdnDescription>NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>120707S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:22.543Z</lastUpdated>
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    <tradeName>HALO XP ELECTROPHYSIOLOGY 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>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36J14R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:07.149Z</lastUpdated>
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    <tradeName>WEBSTER WITH AUTO ID ELECTROPHYSIOLOGY CATHETER</tradeName>
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    <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>
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    <legislation>MDD</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36C38RCT</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:05.549Z</lastUpdated>
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