<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04044508109694</udiDi>
    <basicUdiDi>B-04044508109694</basicUdiDi>
    <tradeName>VACS III 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>YA31230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:18.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109687</udiDi>
    <basicUdiDi>B-04044508109687</basicUdiDi>
    <tradeName>VACS III 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>YA31220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:15.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109670</udiDi>
    <basicUdiDi>B-04044508109670</basicUdiDi>
    <tradeName>VACS III 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>YA31040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:14.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109656</udiDi>
    <basicUdiDi>B-04044508109656</basicUdiDi>
    <tradeName>VACS III 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>YA31020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:13.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109649</udiDi>
    <basicUdiDi>B-04044508109649</basicUdiDi>
    <tradeName>VACS III 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>YA30930</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:09.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109632</udiDi>
    <basicUdiDi>B-04044508109632</basicUdiDi>
    <tradeName>VACS III 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>YA30920</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:08.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109625</udiDi>
    <basicUdiDi>B-04044508109625</basicUdiDi>
    <tradeName>VACS III 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>YA30830</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:07.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109618</udiDi>
    <basicUdiDi>B-04044508109618</basicUdiDi>
    <tradeName>VACS III 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>YA30820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:06.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109601</udiDi>
    <basicUdiDi>B-04044508109601</basicUdiDi>
    <tradeName>VACS III 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>YA30720</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:02.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109595</udiDi>
    <basicUdiDi>B-04044508109595</basicUdiDi>
    <tradeName>VACS III 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>YA30620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:02.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109588</udiDi>
    <basicUdiDi>B-04044508109588</basicUdiDi>
    <tradeName>VACS III 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>YA30520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:01.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109571</udiDi>
    <basicUdiDi>B-04044508109571</basicUdiDi>
    <tradeName>VACS II 30.0 x 60</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>YA0069</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:40:00.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109564</udiDi>
    <basicUdiDi>B-04044508109564</basicUdiDi>
    <tradeName>VACS II 30.0 x 50</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>YA0068</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:56.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109557</udiDi>
    <basicUdiDi>B-04044508109557</basicUdiDi>
    <tradeName>VACS II 30.0 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>YA0067</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:55.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109540</udiDi>
    <basicUdiDi>B-04044508109540</basicUdiDi>
    <tradeName>VACS II 30.0 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>YA0066</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:54.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109533</udiDi>
    <basicUdiDi>B-04044508109533</basicUdiDi>
    <tradeName>VACS II 28.0 x 60</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>YA0065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:54.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109526</udiDi>
    <basicUdiDi>B-04044508109526</basicUdiDi>
    <tradeName>VACS II 28.0 x 50</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>YA0064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:50.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109519</udiDi>
    <basicUdiDi>B-04044508109519</basicUdiDi>
    <tradeName>VACS II 28.0 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>YA0063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:49.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109502</udiDi>
    <basicUdiDi>B-04044508109502</basicUdiDi>
    <tradeName>VACS II 28.0 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>YA0062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:48.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>04044508109496</udiDi>
    <basicUdiDi>B-04044508109496</basicUdiDi>
    <tradeName>VACS II 26.0 x 60</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>YA0061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:47.721Z</lastUpdated>
  </row>
</eudamedExport>