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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>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>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>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>08022057014610</udiDi>
    <basicUdiDi>8022057ROTBICAXB</basicUdiDi>
    <tradeName>Bicarbon Fitline Aortic and Mitral Rotators Set</tradeName>
    <deviceName>Bicarbon Fitline Aortic and Mitral Rotators Set; Bicarbon Overline Aortic Rotators Set; Bicarbon Slimline Aortic Rotators Set;</deviceName>
    <manufacturerName>Corcym S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000027865</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038003</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVE IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICV0732</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:31:41.410Z</lastUpdated>
  </row>
</eudamedExport>