<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10887714009560</udiDi>
    <basicUdiDi>B-10887714009560</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN417</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:53.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009553</udiDi>
    <basicUdiDi>B-10887714009553</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN416</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:52.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009546</udiDi>
    <basicUdiDi>B-10887714009546</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN415</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:51.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009515</udiDi>
    <basicUdiDi>B-10887714009515</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN412</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:47.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009508</udiDi>
    <basicUdiDi>B-10887714009508</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN411</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:46.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009539</udiDi>
    <basicUdiDi>B-10887714009539</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN414</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:45.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009522</udiDi>
    <basicUdiDi>B-10887714009522</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN413</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:45.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009492</udiDi>
    <basicUdiDi>B-10887714009492</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN410</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:28.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009485</udiDi>
    <basicUdiDi>B-10887714009485</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN409</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:27.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009478</udiDi>
    <basicUdiDi>B-10887714009478</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN408</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:26.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009461</udiDi>
    <basicUdiDi>B-10887714009461</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN407</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:25.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009454</udiDi>
    <basicUdiDi>B-10887714009454</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN406</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:21.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009447</udiDi>
    <basicUdiDi>B-10887714009447</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN405</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:21.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009430</udiDi>
    <basicUdiDi>B-10887714009430</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN404</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:20.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009423</udiDi>
    <basicUdiDi>B-10887714009423</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN403</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:19.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009416</udiDi>
    <basicUdiDi>B-10887714009416</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN402</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:15.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009409</udiDi>
    <basicUdiDi>B-10887714009409</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN401</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:14.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714009393</udiDi>
    <basicUdiDi>B-10887714009393</basicUdiDi>
    <tradeName>NuCLEUS-X</tradeName>
    <deviceName>NuCLEUS-X</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVN400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:54:13.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714003636</udiDi>
    <basicUdiDi>B-10887714003636</basicUdiDi>
    <tradeName>COEfficient</tradeName>
    <deviceName>COEfficient</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COE118</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:52:58.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714003612</udiDi>
    <basicUdiDi>B-10887714003612</basicUdiDi>
    <tradeName>COEfficient</tradeName>
    <deviceName>COEfficient</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>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COE148</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:52:56.940Z</lastUpdated>
  </row>
</eudamedExport>