<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-8902618TTKCHVA2K5</udiDi>
    <basicUdiDi>B-8902618TTKCHVA2K5</basicUdiDi>
    <tradeName>TTK Chitra</tradeName>
    <deviceName>TTK Chitra Mechanical Heart Valve</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07030202</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES, SINGLE-DISC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Model TC1 and TC1-H</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:30:29.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001686</udiDi>
    <basicUdiDi>B-00851788001686</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>ONXANE-27/29</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:32.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001679</udiDi>
    <basicUdiDi>B-00851788001679</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>ONXANE-25</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:31.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001662</udiDi>
    <basicUdiDi>B-00851788001662</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>ONXANE-23</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:31.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001655</udiDi>
    <basicUdiDi>B-00851788001655</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>ONXANE-21</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:27.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001648</udiDi>
    <basicUdiDi>B-00851788001648</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>ONXANE-19</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:26.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001549</udiDi>
    <basicUdiDi>B-00851788001549</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</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>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-27/29</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:19.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001532</udiDi>
    <basicUdiDi>B-00851788001532</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</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>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-25</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:18.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001525</udiDi>
    <basicUdiDi>B-00851788001525</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</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>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-23</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:14.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001501</udiDi>
    <basicUdiDi>B-00851788001501</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</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>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-19</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:13.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001471</udiDi>
    <basicUdiDi>B-00851788001471</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-27/29</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:12.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001518</udiDi>
    <basicUdiDi>B-00851788001518</basicUdiDi>
    <tradeName>On-X® Ascending Aortic Prosthesis</tradeName>
    <deviceName>On-X® Ascending Aortic Prosthesis</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>P07030299</emdnCode>
    <emdnDescription>MECHANICAL HEART VALVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONXAAP-21</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:11.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001464</udiDi>
    <basicUdiDi>B-00851788001464</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-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:20:08.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851788001457</udiDi>
    <basicUdiDi>B-00851788001457</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-23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:19:54.361Z</lastUpdated>
  </row>
  <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>
</eudamedExport>