<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SZR35329P</udiDi>
    <basicUdiDi>B-SZR35329P</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>SZR3532</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR3538A3</udiDi>
    <basicUdiDi>B-SZR3538A3</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>SZR3538</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR35439U</udiDi>
    <basicUdiDi>B-SZR35439U</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>SZR3543</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR3546A2</udiDi>
    <basicUdiDi>B-SZR3546A2</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>SZR3546</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR3548A6</udiDi>
    <basicUdiDi>B-SZR3548A6</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>SZR3548</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR401493</udiDi>
    <basicUdiDi>B-SZR401493</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>SZR4014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR40189B</udiDi>
    <basicUdiDi>B-SZR40189B</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>SZR4018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR402394</udiDi>
    <basicUdiDi>B-SZR402394</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>SZR4023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR40289E</udiDi>
    <basicUdiDi>B-SZR40289E</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>SZR4028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR403295</udiDi>
    <basicUdiDi>B-SZR403295</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>SZR4032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR40389H</udiDi>
    <basicUdiDi>B-SZR40389H</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>SZR4038</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SZR40439A</udiDi>
    <basicUdiDi>B-SZR40439A</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>SZR4043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:45.737Z</lastUpdated>
  </row>
  <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>
</eudamedExport>