<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08902618004024</udiDi>
    <basicUdiDi>B-08902618004024</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>19A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:41:22.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902618004017</udiDi>
    <basicUdiDi>B-08902618004017</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>17A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:41:19.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809909406188</udiDi>
    <basicUdiDi>880990940RSSWN</basicUdiDi>
    <tradeName>PULSTA™ Transcatheter Pulmonary Valve System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taewoong Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007515</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSS20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:26.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224973579</udiDi>
    <basicUdiDi>89042249PBE8</basicUdiDi>
    <tradeName>18904224973579</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010201</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBASS1929</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:30:09.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000585259</udiDi>
    <basicUdiDi>0763000B000109982</basicUdiDi>
    <tradeName>Harmony™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301030103</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL PULMONARY VALVES FOR PERCUTANEOUS IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HARMONY-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T09:13:48.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260508661028</udiDi>
    <basicUdiDi>426050866THVAOXXXXG1REAC</basicUdiDi>
    <tradeName>ALLEGRA Transcatheter Heart Valve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NVT GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P070301030201</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL AORTIC VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THV-AO0027G1RE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T23:34:51.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260508661035</udiDi>
    <basicUdiDi>426050866THVAOXXXXG1REAC</basicUdiDi>
    <tradeName>ALLEGRA Transcatheter Heart Valve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NVT GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P070301030201</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL AORTIC VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THV-AO0031G1RE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T23:34:51.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260508661073</udiDi>
    <basicUdiDi>426050866DSLAOXXG2REXXXSJ</basicUdiDi>
    <tradeName>IMPERIA-S Delivery System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NVT GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL-AO18G2115S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T23:34:51.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000526993</udiDi>
    <basicUdiDi>0763000B00007568C</basicUdiDi>
    <tradeName>Avalus™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:37:50.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000527006</udiDi>
    <basicUdiDi>0763000B00007568C</basicUdiDi>
    <tradeName>Avalus™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:37:50.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000527013</udiDi>
    <basicUdiDi>0763000B00007568C</basicUdiDi>
    <tradeName>Avalus™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:37:50.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000527020</udiDi>
    <basicUdiDi>0763000B00007568C</basicUdiDi>
    <tradeName>Avalus™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40027</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:37:50.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000527037</udiDi>
    <basicUdiDi>0763000B00007568C</basicUdiDi>
    <tradeName>Avalus™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010101</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40029</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:37:50.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000825454</udiDi>
    <basicUdiDi>0763000B00024838E</basicUdiDi>
    <tradeName>Avalus Ultra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010201</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400U21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:36:17.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000825461</udiDi>
    <basicUdiDi>0763000B00024838E</basicUdiDi>
    <tradeName>Avalus Ultra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010201</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400U23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:36:17.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000825478</udiDi>
    <basicUdiDi>0763000B00024838E</basicUdiDi>
    <tradeName>Avalus Ultra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010201</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400U25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:36:17.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000825485</udiDi>
    <basicUdiDi>0763000B00024838E</basicUdiDi>
    <tradeName>Avalus Ultra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010201</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400U27</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:36:17.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000825492</udiDi>
    <basicUdiDi>0763000B00024838E</basicUdiDi>
    <tradeName>Avalus Ultra™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010201</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400U29</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:36:17.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224951171</udiDi>
    <basicUdiDi>89042249PBE8</basicUdiDi>
    <tradeName>Dafodil™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010201</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDL29A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:05:40.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224951188</udiDi>
    <basicUdiDi>89042249PBE8</basicUdiDi>
    <tradeName>Dafodil™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Life Sciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008308</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070301010201</emdnCode>
    <emdnDescription>STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDL33M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:05:40.481Z</lastUpdated>
  </row>
</eudamedExport>