<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00851788001792</udiDi>
    <basicUdiDi>B-00851788001792</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>ONXI3-25MR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:38.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001747</udiDi>
    <basicUdiDi>B-00851788001747</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Tray</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Tray (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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONX13-CT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:37.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001730</udiDi>
    <basicUdiDi>B-00851788001730</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Kit</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Kit (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>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI3-CK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:33.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001686</udiDi>
    <basicUdiDi>B-00851788001686</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve</tradeName>
    <deviceName>On-X Prosthetic Heart Valve</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0703020301</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL AORTIC VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXANE-27/29</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:32.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001679</udiDi>
    <basicUdiDi>B-00851788001679</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve</tradeName>
    <deviceName>On-X Prosthetic Heart Valve</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0703020301</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL AORTIC VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXANE-25</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:31.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001662</udiDi>
    <basicUdiDi>B-00851788001662</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve</tradeName>
    <deviceName>On-X Prosthetic Heart Valve</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0703020301</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL AORTIC VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXANE-23</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:31.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001655</udiDi>
    <basicUdiDi>B-00851788001655</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve</tradeName>
    <deviceName>On-X Prosthetic Heart Valve</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0703020301</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL AORTIC VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXANE-21</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:27.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001648</udiDi>
    <basicUdiDi>B-00851788001648</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve</tradeName>
    <deviceName>On-X Prosthetic Heart Valve</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0703020301</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL AORTIC VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXANE-19</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:26.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001587</udiDi>
    <basicUdiDi>B-00851788001587</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>ONXI3-25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:25.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001570</udiDi>
    <basicUdiDi>B-00851788001570</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>ONXI3-27-33S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:24.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001563</udiDi>
    <basicUdiDi>B-00851788001563</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>ONXI3-23-25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:20.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001556</udiDi>
    <basicUdiDi>B-00851788001556</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>ONXI3-27-29S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:19.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001549</udiDi>
    <basicUdiDi>B-00851788001549</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-27/29</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:19.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001532</udiDi>
    <basicUdiDi>B-00851788001532</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-25</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:18.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001525</udiDi>
    <basicUdiDi>B-00851788001525</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-23</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:14.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001501</udiDi>
    <basicUdiDi>B-00851788001501</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-19</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:13.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001471</udiDi>
    <basicUdiDi>B-00851788001471</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve</tradeName>
    <deviceName>On-X Prosthetic Heart Valve</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0703020301</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL AORTIC VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXACE-27/29</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:12.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001518</udiDi>
    <basicUdiDi>B-00851788001518</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-21</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:11.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001464</udiDi>
    <basicUdiDi>B-00851788001464</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve</tradeName>
    <deviceName>On-X Prosthetic Heart Valve</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0703020301</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL AORTIC VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXACE-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:08.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001457</udiDi>
    <basicUdiDi>B-00851788001457</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve</tradeName>
    <deviceName>On-X Prosthetic Heart Valve</deviceName>
    <manufacturerName>On-X Life Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026354</manufacturerSrn>
    <authorisedRepresentativeName>JOTEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006801</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0703020301</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL AORTIC VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXACE-23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:54.361Z</lastUpdated>
  </row>
</eudamedExport>