<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10887714027366</udiDi>
    <basicUdiDi>B-10887714027366</basicUdiDi>
    <tradeName>Covered Mounted CP Stent</tradeName>
    <deviceName>Covered Mounted CP Stent</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070401020199</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCP003</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:31:01.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714027359</udiDi>
    <basicUdiDi>B-10887714027359</basicUdiDi>
    <tradeName>Covered Mounted CP Stent</tradeName>
    <deviceName>Covered Mounted CP Stent</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070401020199</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCP002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:31:00.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714027342</udiDi>
    <basicUdiDi>B-10887714027342</basicUdiDi>
    <tradeName>Covered Mounted CP Stent</tradeName>
    <deviceName>Covered Mounted CP Stent</deviceName>
    <manufacturerName>NuMED, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010948</manufacturerSrn>
    <authorisedRepresentativeName>EVOMED S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000047116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070401020199</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCP001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:30:59.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488107666</udiDi>
    <basicUdiDi>B-04987488107666</basicUdiDi>
    <tradeName>Najuta Thoracic Stent Graft System</tradeName>
    <deviceName>Najuta Thoracic Stent Graft System</deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR8L-S42CL3-3U95</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:07.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488107659</udiDi>
    <basicUdiDi>B-04987488107659</basicUdiDi>
    <tradeName>Najuta Thoracic Stent Graft System</tradeName>
    <deviceName>Najuta Thoracic Stent Graft System</deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR8L-S42CL2-3U95</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:06.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488107635</udiDi>
    <basicUdiDi>B-04987488107635</basicUdiDi>
    <tradeName>Najuta Thoracic Stent Graft System</tradeName>
    <deviceName>Najuta Thoracic Stent Graft System</deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR8L-S42CL3-3U95</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:05.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488107611</udiDi>
    <basicUdiDi>B-04987488107611</basicUdiDi>
    <tradeName>Najuta Thoracic Stent Graft System</tradeName>
    <deviceName>Najuta Thoracic Stent Graft System</deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR8L-S42CL3-3U95</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:04.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>04043584158411</udiDi>
    <basicUdiDi>B-04043584158411</basicUdiDi>
    <tradeName>04043584158411</tradeName>
    <deviceName>E-vita OPEN NEO</deviceName>
    <manufacturerName>JOTEC GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95HG2620L120-C01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:33:20.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450527238</udiDi>
    <basicUdiDi>B-00884450527238</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-L14080/EUA</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:59:41.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450527283</udiDi>
    <basicUdiDi>B-00884450527283</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-L16070/EUA</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:59:39.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450526989</udiDi>
    <basicUdiDi>B-00884450526989</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-L08050/EUA</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:59:25.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450526927</udiDi>
    <basicUdiDi>B-00884450526927</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-L07050/EUA</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:59:21.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850007370978</udiDi>
    <basicUdiDi>B-00850007370978</basicUdiDi>
    <tradeName>Auto Injector 2</tradeName>
    <deviceName>Auto Injector 2</deviceName>
    <manufacturerName>Endologix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010202</manufacturerSrn>
    <authorisedRepresentativeName>Endologix International Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006044</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV-AI01-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:29.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850007370961</udiDi>
    <basicUdiDi>B-00850007370961</basicUdiDi>
    <tradeName>Alto™ Aortic Body Stent Graft</tradeName>
    <deviceName>Alto™ Aortic Body Stent Graft</deviceName>
    <manufacturerName>Endologix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010202</manufacturerSrn>
    <authorisedRepresentativeName>Endologix International Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006044</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV-AB3480-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:26.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850007370954</udiDi>
    <basicUdiDi>B-00850007370954</basicUdiDi>
    <tradeName>Alto™ Aortic Body Stent Graft</tradeName>
    <deviceName>Alto™ Aortic Body Stent Graft</deviceName>
    <manufacturerName>Endologix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010202</manufacturerSrn>
    <authorisedRepresentativeName>Endologix International Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006044</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV-AB2980-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:25.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850007370947</udiDi>
    <basicUdiDi>B-00850007370947</basicUdiDi>
    <tradeName>Alto™ Aortic Body Stent Graft</tradeName>
    <deviceName>Alto™ Aortic Body Stent Graft</deviceName>
    <manufacturerName>Endologix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010202</manufacturerSrn>
    <authorisedRepresentativeName>Endologix International Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006044</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV-AB2680-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:24.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850007370930</udiDi>
    <basicUdiDi>B-00850007370930</basicUdiDi>
    <tradeName>Alto™ Aortic Body Stent Graft</tradeName>
    <deviceName>Alto™ Aortic Body Stent Graft</deviceName>
    <manufacturerName>Endologix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010202</manufacturerSrn>
    <authorisedRepresentativeName>Endologix International Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006044</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV-AB2380-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:22.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850007370923</udiDi>
    <basicUdiDi>B-00850007370923</basicUdiDi>
    <tradeName>Alto™ Aortic Body Stent Graft</tradeName>
    <deviceName>Alto™ Aortic Body Stent Graft</deviceName>
    <manufacturerName>Endologix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010202</manufacturerSrn>
    <authorisedRepresentativeName>Endologix International Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006044</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV-AB2080-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:20.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850007370725</udiDi>
    <basicUdiDi>B-00850007370725</basicUdiDi>
    <tradeName>P07040199</tradeName>
    <deviceName>Ovation iX™ Iliac Limb Stent Graft</deviceName>
    <manufacturerName>Endologix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010202</manufacturerSrn>
    <authorisedRepresentativeName>Endologix International Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006044</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV-IL141680-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:18.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850007370688</udiDi>
    <basicUdiDi>B-00850007370688</basicUdiDi>
    <tradeName>Ovation iX™ Iliac Limb Stent Graft</tradeName>
    <deviceName>Ovation iX™ Iliac Limb Stent Graft</deviceName>
    <manufacturerName>Endologix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010202</manufacturerSrn>
    <authorisedRepresentativeName>Endologix International Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006044</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV-IL1416100-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:17.862Z</lastUpdated>
  </row>
</eudamedExport>