<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00851788001082</udiDi>
    <basicUdiDi>B-00851788001082</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Sizer</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Sizer (Grey)</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038001</emdnCode>
    <emdnDescription>HEART VALVE IMPLANT SIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI2-19S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:11.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001068</udiDi>
    <basicUdiDi>B-00851788001068</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Sizer</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Sizer (Gold)</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038001</emdnCode>
    <emdnDescription>HEART VALVE IMPLANT SIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI3-19S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:11.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001044</udiDi>
    <basicUdiDi>B-00851788001044</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Rotator</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Rotator</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI2-23R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:09.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001037</udiDi>
    <basicUdiDi>B-00851788001037</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Rotator</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Rotator</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI2-21R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:18:53.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001020</udiDi>
    <basicUdiDi>B-00851788001020</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Rotator</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Rotator</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI2-19R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:18:52.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001006</udiDi>
    <basicUdiDi>B-00851788001006</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Kit</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Kit (Grey)</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI2-CK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:18:51.773Z</lastUpdated>
  </row>
  <row>
    <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>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>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>08809909406188</udiDi>
    <basicUdiDi>880990940RSSWN</basicUdiDi>
    <tradeName>PULSTA™ Transcatheter Pulmonary Valve System</tradeName>
    <deviceName></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>RSS20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:26.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260508661073</udiDi>
    <basicUdiDi>426050866DSLAOXXG2REXXXSJ</basicUdiDi>
    <tradeName>IMPERIA-S Delivery System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NVT GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL-AO18G2115S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T23:34:51.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971507751259</udiDi>
    <basicUdiDi>69715077500028V</basicUdiDi>
    <tradeName>Dragonfly™ Accessories</tradeName>
    <deviceName></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-T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:48:45.236Z</lastUpdated>
  </row>
</eudamedExport>