<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04044508137222</udiDi>
    <basicUdiDi>4044508TXCablesU2</basicUdiDi>
    <tradeName>TX-HAT500-SJM m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:17.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137246</udiDi>
    <basicUdiDi>4044508TXCablesU2</basicUdiDi>
    <tradeName>TX-HAT500-BSW</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:17.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137260</udiDi>
    <basicUdiDi>4044508TXCablesU2</basicUdiDi>
    <tradeName>TX-HAT500-MDT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:17.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137284</udiDi>
    <basicUdiDi>4044508TXCablesU2</basicUdiDi>
    <tradeName>TX-HAT500-BIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:17.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137444</udiDi>
    <basicUdiDi>4044508PKCablesJR</basicUdiDi>
    <tradeName>PK-147</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>398853</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:17.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137468</udiDi>
    <basicUdiDi>4044508PKCablesJR</basicUdiDi>
    <tradeName>PK-150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402668</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:17.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137505</udiDi>
    <basicUdiDi>4044508CXCablesHX</basicUdiDi>
    <tradeName>CX-HAT500-BSW THR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:16.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137529</udiDi>
    <basicUdiDi>4044508CXCablesHX</basicUdiDi>
    <tradeName>CX-HAT 500-Smartablate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:16.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137543</udiDi>
    <basicUdiDi>4044508CXCablesHX</basicUdiDi>
    <tradeName>CX-HAT 500-Abbott</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:16.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137567</udiDi>
    <basicUdiDi>4044508CXCablesHX</basicUdiDi>
    <tradeName>CX-BSW-Abbott</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:16.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137581</udiDi>
    <basicUdiDi>4044508CXCablesHX</basicUdiDi>
    <tradeName>CX-HAT500-Maestro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:16.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137604</udiDi>
    <basicUdiDi>4044508CXCablesHX</basicUdiDi>
    <tradeName>CX-HAT500-Maestro THR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:16.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508140284</udiDi>
    <basicUdiDi>4044508PKCablesJR</basicUdiDi>
    <tradeName>PK-162</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>484065</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:16.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506041656</udiDi>
    <basicUdiDi>01915060000000000000670NK</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></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>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T17:19:02.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506041663</udiDi>
    <basicUdiDi>01915060000000000000670NK</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></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>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T17:19:02.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506042479</udiDi>
    <basicUdiDi>01915060000000000000537NG</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></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>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T17:19:02.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506042486</udiDi>
    <basicUdiDi>01915060000000000000537NG</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></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>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T17:19:02.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506042493</udiDi>
    <basicUdiDi>01915060000000000000537NG</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></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>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T17:19:02.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506042509</udiDi>
    <basicUdiDi>01915060000000000000537NG</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></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>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T17:19:02.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506042554</udiDi>
    <basicUdiDi>01915060000000000000537NG</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName></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>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T17:19:02.694Z</lastUpdated>
  </row>
</eudamedExport>