<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>00851788001181</udiDi>
    <basicUdiDi>B-00851788001181</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>ONXI3-21S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:31.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001174</udiDi>
    <basicUdiDi>B-00851788001174</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Tray</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Tray (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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI2-CT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:29.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001167</udiDi>
    <basicUdiDi>B-00851788001167</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Leaflet Probe</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Leaflet Probe</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-LP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:27.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001150</udiDi>
    <basicUdiDi>B-00851788001150</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Handle</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Handle</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-H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:25.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001143</udiDi>
    <basicUdiDi>B-00851788001143</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>ONXI2-27-29S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:24.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001136</udiDi>
    <basicUdiDi>B-00851788001136</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>ONXI2-23-25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:23.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001129</udiDi>
    <basicUdiDi>B-00851788001129</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>ONXI2-27-33S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:19.844Z</lastUpdated>
  </row>
</eudamedExport>