<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00817508015326</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>Artık piyasada değil</deviceStatus>
    <reference>VIR4041</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T14:51:36.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498151090EE</udiDi>
    <basicUdiDi>B-8683498151090EE</basicUdiDi>
    <tradeName>STENA</tradeName>
    <deviceName>Stena Stent System 07*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>STN0760160</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:40:56.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450527733</udiDi>
    <basicUdiDi>B-00884450527733</basicUdiDi>
    <tradeName>WRAPSODY™</tradeName>
    <deviceName>Wrapsody Cell-Impermeable Endoprosthesis</deviceName>
    <manufacturerName>Merit Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001366</manufacturerSrn>
    <authorisedRepresentativeName>Merit Medical Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001011</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRAP-S08075/EUA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:35:54.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR4041ZB</udiDi>
    <basicUdiDi>B-VCR4041ZB</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>VCR4041</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:15:06.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR4038ZN</udiDi>
    <basicUdiDi>B-VCR4038ZN</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>VCR4038</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:15:04.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR4032ZA</udiDi>
    <basicUdiDi>B-VCR4032ZA</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>VCR4032</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:15:02.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR4028ZK</udiDi>
    <basicUdiDi>B-VCR4028ZK</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>VCR4028</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:15:02.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR4023Z9</udiDi>
    <basicUdiDi>B-VCR4023Z9</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>VCR4023</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:59.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR4018ZG</udiDi>
    <basicUdiDi>B-VCR4018ZG</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>VCR4018</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:58.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR4015ZA</udiDi>
    <basicUdiDi>B-VCR4015ZA</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>VCR4015</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:54.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR35482E</udiDi>
    <basicUdiDi>B-VCR35482E</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>VCR3548</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:53.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR35462A</udiDi>
    <basicUdiDi>B-VCR35462A</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>VCR3546</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:52.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR354324</udiDi>
    <basicUdiDi>B-VCR354324</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>VCR3543</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:50.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR35382B</udiDi>
    <basicUdiDi>B-VCR35382B</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>VCR3538</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:48.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR3532ZU</udiDi>
    <basicUdiDi>B-VCR3532ZU</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>VCR3532</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:46.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR352828</udiDi>
    <basicUdiDi>B-VCR352828</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>VCR3528</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:46.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR3523ZT</udiDi>
    <basicUdiDi>B-VCR3523ZT</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>VCR3523</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:44.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR351825</udiDi>
    <basicUdiDi>B-VCR351825</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>VCR3518</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:42.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR3514ZS</udiDi>
    <basicUdiDi>B-VCR3514ZS</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>VCR3514</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:40.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VCR3048ZJ</udiDi>
    <basicUdiDi>B-VCR3048ZJ</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>VCR3048</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:14:39.889Z</lastUpdated>
  </row>
</eudamedExport>