<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>00851788001112</udiDi>
    <basicUdiDi>B-00851788001112</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>ONXI2-25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:18.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001105</udiDi>
    <basicUdiDi>B-00851788001105</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>ONX12-23S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:17.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001099</udiDi>
    <basicUdiDi>B-00851788001099</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>ONXI2-21S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:15.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001051</udiDi>
    <basicUdiDi>B-00851788001051</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>ONXI2-25R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:13.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001082</udiDi>
    <basicUdiDi>B-00851788001082</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>ONXI2-19S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:11.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001068</udiDi>
    <basicUdiDi>B-00851788001068</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>ONXI3-19S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:11.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001044</udiDi>
    <basicUdiDi>B-00851788001044</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>ONXI2-23R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:09.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001037</udiDi>
    <basicUdiDi>B-00851788001037</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>ONXI2-21R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:18:53.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001020</udiDi>
    <basicUdiDi>B-00851788001020</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>ONXI2-19R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:18:52.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001006</udiDi>
    <basicUdiDi>B-00851788001006</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Kit</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Kit (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>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI2-CK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:18:51.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898226</udiDi>
    <basicUdiDi>B-00850000898226</basicUdiDi>
    <tradeName>Trilogy Heart Valve</tradeName>
    <deviceName>Trilogy Transcatheter Heart Valve</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-THV-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:07.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898219</udiDi>
    <basicUdiDi>B-00850000898219</basicUdiDi>
    <tradeName>Trilogy Heart Valve</tradeName>
    <deviceName>Trilogy Transcatheter Heart Valve</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-THV-M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:06.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850000898202</udiDi>
    <basicUdiDi>B-00850000898202</basicUdiDi>
    <tradeName>Trilogy Heart Valve</tradeName>
    <deviceName>Trilogy Transcatheter Heart Valve</deviceName>
    <manufacturerName>JenaValve Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023455</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRILOGY-THV-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:03.934Z</lastUpdated>
  </row>
</eudamedExport>