<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SZR27239R</udiDi>
    <basicUdiDi>B-SZR27239R</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2723</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR2728A3</udiDi>
    <basicUdiDi>B-SZR2728A3</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2728</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR27329S</udiDi>
    <basicUdiDi>B-SZR27329S</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2732</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR2738A6</udiDi>
    <basicUdiDi>B-SZR2738A6</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2738</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR27439X</udiDi>
    <basicUdiDi>B-SZR27439X</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2743</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR2746A5</udiDi>
    <basicUdiDi>B-SZR2746A5</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2746</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR2748A9</udiDi>
    <basicUdiDi>B-SZR2748A9</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR2748</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR30148U</udiDi>
    <basicUdiDi>B-SZR30148U</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR301894</udiDi>
    <basicUdiDi>B-SZR301894</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR30238V</udiDi>
    <basicUdiDi>B-SZR30238V</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR302897</udiDi>
    <basicUdiDi>B-SZR302897</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR30328W</udiDi>
    <basicUdiDi>B-SZR30328W</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR30389A</udiDi>
    <basicUdiDi>B-SZR30389A</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3038</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR304393</udiDi>
    <basicUdiDi>B-SZR304393</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:46.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR304699</udiDi>
    <basicUdiDi>B-SZR304699</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3046</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR30489D</udiDi>
    <basicUdiDi>B-SZR30489D</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR35149M</udiDi>
    <basicUdiDi>B-SZR35149M</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR35189V</udiDi>
    <basicUdiDi>B-SZR35189V</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3518</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR35239N</udiDi>
    <basicUdiDi>B-SZR35239N</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3523</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR35289Y</udiDi>
    <basicUdiDi>B-SZR35289Y</basicUdiDi>
    <tradeName>DESyne® X2 Novolimus Eluting Coronary Stent 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></emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SZR3528</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.909Z</lastUpdated>
  </row>
</eudamedExport>