<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00817508014992</udiDi>
    <basicUdiDi>081750801LithiXY7</basicUdiDi>
    <tradeName>LithiX Hertz Contact Intravascular Lithotripsy Catheter [EN]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C01040199</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:38:03.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508014985</udiDi>
    <basicUdiDi>081750801LithiXY7</basicUdiDi>
    <tradeName>LithiX Hertz Contact Intravascular Lithotripsy Catheter [EN]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C01040199</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:38:02.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508014978</udiDi>
    <basicUdiDi>081750801LithiXY7</basicUdiDi>
    <tradeName>LithiX Hertz Contact Intravascular Lithotripsy Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C01040199</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:38:01.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013674</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:38:00.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013667</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:59.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013650</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:58.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013643</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:57.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013636</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:55.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013629</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:54.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013087</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:53.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013070</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:52.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013063</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:51.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013056</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:50.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013049</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:49.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013018</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:44.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508013001</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:43.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012998</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:42.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012981</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:41.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012974</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:40.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012967</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:37:38.975Z</lastUpdated>
  </row>
</eudamedExport>