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<eudamedExport entity="devices">
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    <udiDi>00850000898196</udiDi>
    <basicUdiDi>B-00850000898196</basicUdiDi>
    <tradeName>Trilogy Sheath/Dilator</tradeName>
    <deviceName>Trilogy Sheath/Dilator</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-INT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:02.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898189</udiDi>
    <basicUdiDi>B-00850000898189</basicUdiDi>
    <tradeName>Trilogy Loading Tools</tradeName>
    <deviceName>Trilogy Loading Tools Size 27</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-LT-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:01.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898172</udiDi>
    <basicUdiDi>B-00850000898172</basicUdiDi>
    <tradeName>Trilogy Loading Tools</tradeName>
    <deviceName>Trilogy Loading Tools Size 25</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-LT-M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:59.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898165</udiDi>
    <basicUdiDi>B-00850000898165</basicUdiDi>
    <tradeName>Trilogy Loading Tools</tradeName>
    <deviceName>Trilogy Loading Tools Size 23</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-LT-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:57.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898158</udiDi>
    <basicUdiDi>B-00850000898158</basicUdiDi>
    <tradeName>Trilogy Delivery Catheter</tradeName>
    <deviceName>Trilogy Delivery Catheter Size 27</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-DC-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:55.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898141</udiDi>
    <basicUdiDi>B-00850000898141</basicUdiDi>
    <tradeName>Trilogy Delivery Catheter</tradeName>
    <deviceName>Trilogy Delivery Catheter Size 25</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-DC-M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:55.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898134</udiDi>
    <basicUdiDi>B-00850000898134</basicUdiDi>
    <tradeName>Trilogy Delivery Catheter</tradeName>
    <deviceName>Trilogy Delivery Catheter Size 23</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-DC-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:53.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898127</udiDi>
    <basicUdiDi>B-00850000898127</basicUdiDi>
    <tradeName>Trilogy Heart Valve</tradeName>
    <deviceName>Trilogy Heart Valve Size 27</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-THV-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:51.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898110</udiDi>
    <basicUdiDi>B-00850000898110</basicUdiDi>
    <tradeName>Trilogy Heart Valve</tradeName>
    <deviceName>Trilogy Heart Valve Size 25</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-THV-M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:49.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898103</udiDi>
    <basicUdiDi>B-00850000898103</basicUdiDi>
    <tradeName>Trilogy Heart Valve</tradeName>
    <deviceName>Trilogy Heart Valve Size 23</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-THV-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:48.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627843217848</udiDi>
    <basicUdiDi>B-00627843217848</basicUdiDi>
    <tradeName>Handle for Extra Aortic annuloplasty ring</tradeName>
    <deviceName>Handle for Extra Aortic annuloplasty ring</deviceName>
    <manufacturerName>Coroneo Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000019141</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038099</emdnCode>
    <emdnDescription>HEART VALVE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100312</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:22.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224914299</udiDi>
    <basicUdiDi>89042249PBE8</basicUdiDi>
    <tradeName>Dafodil™</tradeName>
    <deviceName>Dafodil™ Pericardial Bioprosthesis Valve</deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010201</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDL19A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:29:14.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809909406171</udiDi>
    <basicUdiDi>880990940RSSWN</basicUdiDi>
    <tradeName>PULSTA ™ Transcatheter Pulmonary Valve System</tradeName>
    <deviceName>Crimping Tool</deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSS18</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:04:40.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>08022057014610</udiDi>
    <basicUdiDi>8022057ROTBICAXB</basicUdiDi>
    <tradeName>Bicarbon Fitline Aortic and Mitral Rotators Set</tradeName>
    <deviceName>Bicarbon Fitline Aortic and Mitral Rotators Set; Bicarbon Overline Aortic Rotators Set; Bicarbon Slimline Aortic Rotators Set;</deviceName>
    <manufacturerName>Corcym S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000027865</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICV0732</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:31:41.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971507751242</udiDi>
    <basicUdiDi>69715077500028V</basicUdiDi>
    <tradeName>Dragonfly™ Accessories</tradeName>
    <deviceName>Dragonfly™ Accessories</deviceName>
    <manufacturerName>Hangzhou Valgen Medtech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037140</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSS-45-45-20-S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:59:17.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260642340001</udiDi>
    <basicUdiDi>426064234TricValveBM</basicUdiDi>
    <tradeName>TricValve® Transcatheter Bicaval Valve System - SVC 25</tradeName>
    <deviceName></deviceName>
    <manufacturerName>P+F Products and Features GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008580</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07030104</emdnCode>
    <emdnDescription>BIOLOGICAL VALVES, BICAVAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF01020025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:50:45.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004550</udiDi>
    <basicUdiDi>B-08902618004550</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 33mm</deviceName>
    <manufacturerName>TTK Healthcare Limited Heart Valve Division</manufacturerName>
    <manufacturerSrn>IN-MF-000022265</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030202</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES, SINGLE-DISC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33M</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:19.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004543</udiDi>
    <basicUdiDi>B-08902618004543</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 33mm</deviceName>
    <manufacturerName>TTK Healthcare Limited Heart Valve Division</manufacturerName>
    <manufacturerSrn>IN-MF-000022265</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030202</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES, SINGLE-DISC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33MH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:17.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004536</udiDi>
    <basicUdiDi>B-08902618004536</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 31mm</deviceName>
    <manufacturerName>TTK Healthcare Limited Heart Valve Division</manufacturerName>
    <manufacturerSrn>IN-MF-000022265</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030202</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES, SINGLE-DISC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31MH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:16.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004529</udiDi>
    <basicUdiDi>B-08902618004529</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 29mm</deviceName>
    <manufacturerName>TTK Healthcare Limited Heart Valve Division</manufacturerName>
    <manufacturerSrn>IN-MF-000022265</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030202</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES, SINGLE-DISC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29MH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:13.741Z</lastUpdated>
  </row>
</eudamedExport>