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