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<eudamedExport entity="devices">
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    <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>
  <row>
    <udiDi>00851788001440</udiDi>
    <basicUdiDi>B-00851788001440</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-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:51.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001433</udiDi>
    <basicUdiDi>B-00851788001433</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-19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:51.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001426</udiDi>
    <basicUdiDi>B-00851788001426</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>ONXAE-27/29</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:49.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001419</udiDi>
    <basicUdiDi>B-00851788001419</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>ONXAE-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:47.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001402</udiDi>
    <basicUdiDi>B-00851788001402</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>ONXAE-23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:45.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001396</udiDi>
    <basicUdiDi>B-00851788001396</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>ONXAE-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:44.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001389</udiDi>
    <basicUdiDi>B-00851788001389</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>ONXAE-19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:43.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001303</udiDi>
    <basicUdiDi>B-00851788001303</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>P0703020302</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL MITRAL VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXMC-25/33</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:40.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001297</udiDi>
    <basicUdiDi>B-00851788001297</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>P0703020302</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL MITRAL VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXM-31/33</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:38.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001280</udiDi>
    <basicUdiDi>B-00851788001280</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>P0703020302</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL MITRAL VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXM-27/29</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:37.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001273</udiDi>
    <basicUdiDi>B-00851788001273</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>P0703020302</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL MITRAL VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXM-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:35.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001266</udiDi>
    <basicUdiDi>B-00851788001266</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>P0703020302</emdnCode>
    <emdnDescription>BILEAFLET MECHANICAL MITRAL VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXM-23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:33.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001198</udiDi>
    <basicUdiDi>B-00851788001198</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>ONXI3-23S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:31.855Z</lastUpdated>
  </row>
</eudamedExport>