<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>18904224961002</udiDi>
    <basicUdiDi>B-18904224961002</basicUdiDi>
    <tradeName>Myval OCTACOR™</tradeName>
    <deviceName>Myval OCTACOR™ Transcatheter Heart Valve</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>MDD</legislation>
    <emdnCode>P070301030201</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL AORTIC VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOCTA4200</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:41:31.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850035587041</udiDi>
    <basicUdiDi>08500355876311107A</basicUdiDi>
    <tradeName>Valve Loading Tool</tradeName>
    <deviceName>Valve Loading Tool</deviceName>
    <manufacturerName>HighLife</manufacturerName>
    <manufacturerSrn>FR-MF-000015887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038099</emdnCode>
    <emdnDescription>HEART VALVE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>631110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:22:56.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000825447</udiDi>
    <basicUdiDi>0763000B00024838E</basicUdiDi>
    <tradeName>Avalus Ultra™</tradeName>
    <deviceName>Avalus Ultra bioprosthesis</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>400U19</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:08:12.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000647094</udiDi>
    <basicUdiDi>0763000B00026938T</basicUdiDi>
    <tradeName>Avalus Ultra™</tradeName>
    <deviceName>Avalus Ultra Sizers</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>P07038001</emdnCode>
    <emdnDescription>HEART VALVE IMPLANT SIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7400SU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:07:36.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000585242</udiDi>
    <basicUdiDi>0763000B000109982</basicUdiDi>
    <tradeName>Harmony™</tradeName>
    <deviceName>Harmony Transcatheter Pulmonary Valve</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-22</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:06:58.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000582951</udiDi>
    <basicUdiDi>0763000B00010977W</basicUdiDi>
    <tradeName>Harmony™</tradeName>
    <deviceName>Harmony Delivery Catheter System</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>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HARMONY-DCS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:06:58.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000582890</udiDi>
    <basicUdiDi>0763000B00010927L</basicUdiDi>
    <tradeName>Avalus™</tradeName>
    <deviceName>Avalus sizers</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>P07038001</emdnCode>
    <emdnDescription>HEART VALVE IMPLANT SIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7400S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:06:49.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000526986</udiDi>
    <basicUdiDi>0763000B00007568C</basicUdiDi>
    <tradeName>Avalus™</tradeName>
    <deviceName>Avalus bioprosthesis</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>40019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:06:28.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506030971</udiDi>
    <basicUdiDi>01915060000000000000567NR</basicUdiDi>
    <tradeName>ACURATE Prime™</tradeName>
    <deviceName>ACURATE Prime Loading Kit</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H749396942325</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:31.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506019419</udiDi>
    <basicUdiDi>01915060000000000000260MU</basicUdiDi>
    <tradeName>ACURATE neo2™</tradeName>
    <deviceName>ACURATE neo2™ Loading Kit</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYM-AC-010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:55:01.229Z</lastUpdated>
  </row>
  <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>18904224971902</udiDi>
    <basicUdiDi>B-18904224971902</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</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>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVS133535</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:35.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224971889</udiDi>
    <basicUdiDi>B-18904224971889</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</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>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVT133535</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:30.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224971896</udiDi>
    <basicUdiDi>B-18904224971896</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</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>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVT135035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:30.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224971872</udiDi>
    <basicUdiDi>B-18904224971872</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</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>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVS33535</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:28.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224971865</udiDi>
    <basicUdiDi>B-18904224971865</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</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>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVT35035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:27.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224971858</udiDi>
    <basicUdiDi>B-18904224971858</basicUdiDi>
    <tradeName>Navigator™</tradeName>
    <deviceName>Navigator™ Transcatheter Heart Valve Delivery System</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>MDD</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVT33535</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:23.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224971025</udiDi>
    <basicUdiDi>B-18904224971025</basicUdiDi>
    <tradeName>Myval™ OCTAPRO+</tradeName>
    <deviceName>Myval™ OCTAPRO+ Transcatheter Heart Valve</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>MDD</legislation>
    <emdnCode>P070301030201</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL AORTIC VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOCTAPRP5320</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:22.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224971018</udiDi>
    <basicUdiDi>B-18904224971018</basicUdiDi>
    <tradeName>Myval™ OCTAPRO+</tradeName>
    <deviceName>Myval™ OCTAPRO+ Transcatheter Heart Valve</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>MDD</legislation>
    <emdnCode>P070301030201</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL AORTIC VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOCTAPRP5305</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:22.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904224971001</udiDi>
    <basicUdiDi>B-18904224971001</basicUdiDi>
    <tradeName>Myval™ OCTAPRO+</tradeName>
    <deviceName>Myval™ OCTAPRO+ Transcatheter Heart Valve</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>MDD</legislation>
    <emdnCode>P070301030201</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL AORTIC VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOCTAPRP5290</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:26:21.226Z</lastUpdated>
  </row>
</eudamedExport>