<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04044508109137</udiDi>
    <basicUdiDi>B-04044508109137</basicUdiDi>
    <tradeName>VACS II 12.0 x 40</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:42.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109120</udiDi>
    <basicUdiDi>B-04044508109120</basicUdiDi>
    <tradeName>VACS II 12.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:42.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109113</udiDi>
    <basicUdiDi>B-04044508109113</basicUdiDi>
    <tradeName>VACS II 12.0 x 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:26.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109106</udiDi>
    <basicUdiDi>B-04044508109106</basicUdiDi>
    <tradeName>VACS II 10.0 x 40</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:25.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109090</udiDi>
    <basicUdiDi>B-04044508109090</basicUdiDi>
    <tradeName>VACS II 10.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:25.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109083</udiDi>
    <basicUdiDi>B-04044508109083</basicUdiDi>
    <tradeName>VACS II 10.0 x 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:24.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109076</udiDi>
    <basicUdiDi>B-04044508109076</basicUdiDi>
    <tradeName>VACS II 9.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:20.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109069</udiDi>
    <basicUdiDi>B-04044508109069</basicUdiDi>
    <tradeName>VACS II 9.0 x 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:19.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109052</udiDi>
    <basicUdiDi>B-04044508109052</basicUdiDi>
    <tradeName>VACS II 8.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:18.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109045</udiDi>
    <basicUdiDi>B-04044508109045</basicUdiDi>
    <tradeName>VACS II 8.0 x 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:17.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109038</udiDi>
    <basicUdiDi>B-04044508109038</basicUdiDi>
    <tradeName>VACS II 7.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:13.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109021</udiDi>
    <basicUdiDi>B-04044508109021</basicUdiDi>
    <tradeName>VACS II 7.0 x 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:13.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109014</udiDi>
    <basicUdiDi>B-04044508109014</basicUdiDi>
    <tradeName>VACS II 6.0 x 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:12.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109007</udiDi>
    <basicUdiDi>B-04044508109007</basicUdiDi>
    <tradeName>VACS II 5.0 x 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:11.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508108994</udiDi>
    <basicUdiDi>B-04044508108994</basicUdiDi>
    <tradeName>VACS II 4.0 x 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:07.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508140147</udiDi>
    <basicUdiDi>4044508PacingCablesQU</basicUdiDi>
    <tradeName>Cable CV-P |orange|L=1900|</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>C020299</emdnCode>
    <emdnDescription>CARDIAC TEMPORARY STIMULATION DEVICES (WITH OR WITHOUT ACTIVE SUBSTANCES) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81976</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:09:05.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137482</udiDi>
    <basicUdiDi>4044508CXCablesHX</basicUdiDi>
    <tradeName>CX-HAT 500-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>82013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:09:04.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137420</udiDi>
    <basicUdiDi>4044508PKCablesJR</basicUdiDi>
    <tradeName>PK-143-B</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>460041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:09:02.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508137208</udiDi>
    <basicUdiDi>4044508TXCablesU2</basicUdiDi>
    <tradeName>TX-HAT500-SJM f</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>82006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:09:00.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508136980</udiDi>
    <basicUdiDi>4044508iConnectSCS</basicUdiDi>
    <tradeName>iCONNECT - 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>001-009077-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:08:58.642Z</lastUpdated>
  </row>
</eudamedExport>