<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07908249700008</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName>Vascular Stent Graft</deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:15:22.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249704242</udiDi>
    <basicUdiDi>79082497GIANTVD</basicUdiDi>
    <tradeName>Giant S-AT Balloon Catheter</tradeName>
    <deviceName>Peripheral Angioplasty Balloon Catheter</deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128937</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:23:16.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703832</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128093</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703849</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128091</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703856</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128090</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703863</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128092</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703870</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128094</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703887</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128095</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703894</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703900</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128097</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703917</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128098</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703924</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128099</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703931</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703986</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128944</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249703993</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128945</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249704006</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128451</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249704013</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128450</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249704020</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128449</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249704037</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128448</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908249704044</udiDi>
    <basicUdiDi>79082497SOLARISCB</basicUdiDi>
    <tradeName>SOLARIS VASCULAR STENT GRAFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Scitech Produtos Médicos SA</manufacturerName>
    <manufacturerSrn>BR-MF-000018627</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070401020103</emdnCode>
    <emdnDescription>PTFE VASCULAR ENDOPROSTHESES, STRAIGHT - PERIPHERAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128447</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:35:02.172Z</lastUpdated>
  </row>
</eudamedExport>