<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>08902618004550</udiDi>
    <basicUdiDi>B-08902618004550</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 33mm</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>33M</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:19.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004543</udiDi>
    <basicUdiDi>B-08902618004543</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 33mm</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>33MH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:17.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004536</udiDi>
    <basicUdiDi>B-08902618004536</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 31mm</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>31MH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:16.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004529</udiDi>
    <basicUdiDi>B-08902618004529</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 29mm</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>29MH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:13.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004512</udiDi>
    <basicUdiDi>B-08902618004512</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 27mm</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>27MH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:10.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004505</udiDi>
    <basicUdiDi>B-08902618004505</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 25mm</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>25MH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:07.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004499</udiDi>
    <basicUdiDi>B-08902618004499</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Mitral Heart Valve Substitute, Size 23mm</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>23MH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:06.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004482</udiDi>
    <basicUdiDi>B-08902618004482</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Aortic Heart Valve Substitute, Size 29mm</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>29AH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:04.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004475</udiDi>
    <basicUdiDi>B-08902618004475</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Aortic Heart Valve Substitute, Size 27mm</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>27AH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:42:00.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004468</udiDi>
    <basicUdiDi>B-08902618004468</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Aortic Heart Valve Substitute, Size 25mm</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>25AH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:41:58.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004451</udiDi>
    <basicUdiDi>B-08902618004451</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Aortic Heart Valve Substitute, Size 23mm</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>23AH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:41:56.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004444</udiDi>
    <basicUdiDi>B-08902618004444</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Aortic Heart Valve Substitute, Size 21mm</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>21AH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:41:54.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004437</udiDi>
    <basicUdiDi>B-08902618004437</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Aortic Heart Valve Substitute, Size 19mm</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>19AH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:41:50.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004420</udiDi>
    <basicUdiDi>B-08902618004420</basicUdiDi>
    <tradeName>TTK Chitra Mechanical Heart Valve</tradeName>
    <deviceName>Rigid Tilting Disc TTK Chitra Aortic Heart Valve Substitute, Size 17mm</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>17AH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:41:48.517Z</lastUpdated>
  </row>
</eudamedExport>