<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SZR40469G</udiDi>
    <basicUdiDi>B-SZR40469G</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>SZR4046</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR40489L</udiDi>
    <basicUdiDi>B-SZR40489L</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>SZR4048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZRXXXXUK</udiDi>
    <basicUdiDi>B-SZRXXXXUK</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>SZR2214</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2214Z4</udiDi>
    <basicUdiDi>B-VCR2214Z4</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2214</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2218ZC</udiDi>
    <basicUdiDi>B-VCR2218ZC</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2218</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2223Z5</udiDi>
    <basicUdiDi>B-VCR2223Z5</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2228ZF</udiDi>
    <basicUdiDi>B-VCR2228ZF</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2228</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2232Z6</udiDi>
    <basicUdiDi>B-VCR2232Z6</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2232</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2238ZJ</udiDi>
    <basicUdiDi>B-VCR2238ZJ</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2238</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2243ZB</udiDi>
    <basicUdiDi>B-VCR2243ZB</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2243</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2246ZH</udiDi>
    <basicUdiDi>B-VCR2246ZH</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2246</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2248ZM</udiDi>
    <basicUdiDi>B-VCR2248ZM</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2248</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2514ZK</udiDi>
    <basicUdiDi>B-VCR2514ZK</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2518ZT</udiDi>
    <basicUdiDi>B-VCR2518ZT</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2518</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2523ZL</udiDi>
    <basicUdiDi>B-VCR2523ZL</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2523</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2528ZW</udiDi>
    <basicUdiDi>B-VCR2528ZW</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2528</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2532ZM</udiDi>
    <basicUdiDi>B-VCR2532ZM</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2532</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR253824</udiDi>
    <basicUdiDi>B-VCR253824</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2538</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2543ZS</udiDi>
    <basicUdiDi>B-VCR2543ZS</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2543</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR254623</udiDi>
    <basicUdiDi>B-VCR254623</basicUdiDi>
    <tradeName>DynamX Novolimus 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2546</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:30.204Z</lastUpdated>
  </row>
</eudamedExport>