<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00191506007522</udiDi>
    <basicUdiDi>01915060000000000000212MH</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName>SMARTFREEZE CRYO Console Accessories</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>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004CRBS6320</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:54:49.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506000813</udiDi>
    <basicUdiDi>01915060000000000000215MP</basicUdiDi>
    <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>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004RAPATCH20</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:54:48.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860007954153</udiDi>
    <basicUdiDi>00860007954DP-1000vMapBD</basicUdiDi>
    <tradeName>vMap</tradeName>
    <deviceName>Vektor Computational ECG Mapping System (vMap)</deviceName>
    <manufacturerName>Vektor Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047086</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005578</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>714-00001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:39:04.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851913006098</udiDi>
    <basicUdiDi>00856817005Sens3D</basicUdiDi>
    <tradeName>Little PALS</tradeName>
    <deviceName>Sensing Electrodes</deviceName>
    <manufacturerName>Axelgaard Manufacturing Co., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000009382</manufacturerSrn>
    <authorisedRepresentativeName>Axelgaard Manufacturing Co., Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000002096</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEN 3001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:36:07.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>M58800101480010</udiDi>
    <basicUdiDi>++M5880010148001EY</basicUdiDi>
    <tradeName>SynX</tradeName>
    <deviceName>SynX</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>001-014800-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:59:36.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>M58800101070010</udiDi>
    <basicUdiDi>++M5880010107001DD</basicUdiDi>
    <tradeName>Synchrony</tradeName>
    <deviceName>Synchrony System</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>001-010700-1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:59:36.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>M58802000780040</udiDi>
    <basicUdiDi>++M588020007800NB</basicUdiDi>
    <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>
  </row>
  <row>
    <udiDi>M58800100701020</udiDi>
    <basicUdiDi>++M588001007010LH</basicUdiDi>
    <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>
  </row>
  <row>
    <udiDi>+M582NEMEL0020</udiDi>
    <basicUdiDi>++M582NEMELCD</basicUdiDi>
    <tradeName>NEMEL002</tradeName>
    <deviceName>NEMEL electrode patch used with the DR400</deviceName>
    <manufacturerName>NorthEast Monitoring, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019819</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEMEL002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:52:36.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G177ECGMED1</udiDi>
    <basicUdiDi>++G177ECGPADWW</basicUdiDi>
    <tradeName>+G177ECGMED1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ABINTRAX S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019536</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SGFO3742M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:04:17.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>B938AFR000130</udiDi>
    <basicUdiDi>++B938SYSCARTG9</basicUdiDi>
    <tradeName>B938AFR000130</tradeName>
    <deviceName>System Cart</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-00013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:02:36.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>B938AFR000070</udiDi>
    <basicUdiDi>++B938HEXALOCREF01AR</basicUdiDi>
    <tradeName>B938AFR000070</tradeName>
    <deviceName>Location Reference Patch Kit</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-00007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:02:35.391Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <row>
    <udiDi>D-USMF000014219000043QN</udiDi>
    <basicUdiDi>B-USMF000014219000043QN</basicUdiDi>
    <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>
  </row>
  <row>
    <udiDi>D-USMF000014219000042QL</udiDi>
    <basicUdiDi>B-USMF000014219000042QL</basicUdiDi>
    <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>
  </row>
  <row>
    <udiDi>D-USMF000014219000041QJ</udiDi>
    <basicUdiDi>B-USMF000014219000041QJ</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>D131801</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:54.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014219000040QG</udiDi>
    <basicUdiDi>B-USMF000014219000040QG</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>BNI35DJH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:54.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014219000039QX</udiDi>
    <basicUdiDi>B-USMF000014219000039QX</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>BNI35BBH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:49.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014219000038QV</udiDi>
    <basicUdiDi>B-USMF000014219000038QV</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>BNI35DDH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:49.063Z</lastUpdated>
  </row>
</eudamedExport>