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<eudamedExport entity="devices">
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    <udiDi>08902618004574</udiDi>
    <basicUdiDi>B-08902618004574</basicUdiDi>
    <tradeName>08902618004574</tradeName>
    <deviceName>TTK Chitra Heart Valve Accessory Set</deviceName>
    <manufacturerName>TTK Healthcare Limited Heart Valve Division</manufacturerName>
    <manufacturerSrn>IN-MF-000022265</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASTC1-H</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:25:19.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001792</udiDi>
    <basicUdiDi>B-00851788001792</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>ONXI3-25MR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:38.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001747</udiDi>
    <basicUdiDi>B-00851788001747</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Tray</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Tray (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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONX13-CT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:37.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001730</udiDi>
    <basicUdiDi>B-00851788001730</basicUdiDi>
    <tradeName>On-X Prosthetic Heart Valve Instrument Kit</tradeName>
    <deviceName>On-X Prosthetic Heart Valve Instrument Kit (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>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXI3-CK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:33.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001587</udiDi>
    <basicUdiDi>B-00851788001587</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>ONXI3-25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:25.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001570</udiDi>
    <basicUdiDi>B-00851788001570</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>ONXI3-27-33S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:24.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001563</udiDi>
    <basicUdiDi>B-00851788001563</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>ONXI3-23-25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:20.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001556</udiDi>
    <basicUdiDi>B-00851788001556</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>ONXI3-27-29S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:19.939Z</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>
  <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>
</eudamedExport>