<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>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>
</eudamedExport>