<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-VCR253824</udiDi>
    <basicUdiDi>B-VCR253824</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2538</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:53.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2532ZM</udiDi>
    <basicUdiDi>B-VCR2532ZM</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2532</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:50.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2528ZW</udiDi>
    <basicUdiDi>B-VCR2528ZW</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2528</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:50.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2523ZL</udiDi>
    <basicUdiDi>B-VCR2523ZL</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2523</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:50.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2518ZT</udiDi>
    <basicUdiDi>B-VCR2518ZT</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2518</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:46.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2514ZK</udiDi>
    <basicUdiDi>B-VCR2514ZK</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2514</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:44.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2248ZM</udiDi>
    <basicUdiDi>B-VCR2248ZM</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2248</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:42.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2246ZH</udiDi>
    <basicUdiDi>B-VCR2246ZH</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2246</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:41.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2243ZB</udiDi>
    <basicUdiDi>B-VCR2243ZB</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2243</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:40.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2238ZJ</udiDi>
    <basicUdiDi>B-VCR2238ZJ</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2238</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:37.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2232Z6</udiDi>
    <basicUdiDi>B-VCR2232Z6</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2232</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:36.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2228ZF</udiDi>
    <basicUdiDi>B-VCR2228ZF</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2228</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:35.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2223Z5</udiDi>
    <basicUdiDi>B-VCR2223Z5</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2223</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:33.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2218ZC</udiDi>
    <basicUdiDi>B-VCR2218ZC</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2218</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:32.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR2214Z4</udiDi>
    <basicUdiDi>B-VCR2214Z4</basicUdiDi>
    <tradeName>DynamX Novolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Novolimus Eluting Coronary Bioadaptor System</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>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCR2214</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:29.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498151083EH</udiDi>
    <basicUdiDi>B-8683498151083EH</basicUdiDi>
    <tradeName>STENA</tradeName>
    <deviceName>Stena Stent System 07*90*160, 6F</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STN0790160</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:27:53.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498151076EL</udiDi>
    <basicUdiDi>B-8683498151076EL</basicUdiDi>
    <tradeName>STENA</tradeName>
    <deviceName>Stena Stent System 08*20*160, 6F</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STN0820160</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:27:53.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498151069EP</udiDi>
    <basicUdiDi>B-8683498151069EP</basicUdiDi>
    <tradeName>STENA</tradeName>
    <deviceName>Stena Stent System 08*40*160, 6F</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STN0840160</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:27:49.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498151052E6</udiDi>
    <basicUdiDi>B-8683498151052E6</basicUdiDi>
    <tradeName>STENA</tradeName>
    <deviceName>Stena Stent System 08*60*160, 6F</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STN0860160</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:27:49.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498151045E9</udiDi>
    <basicUdiDi>B-8683498151045E9</basicUdiDi>
    <tradeName>STENA</tradeName>
    <deviceName>Stena Stent System 08*80*160, 6F</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STN0880160</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:27:49.174Z</lastUpdated>
  </row>
</eudamedExport>