<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10887714032964</udiDi>
    <basicUdiDi>B-10887714032964</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN227</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:33:01.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714032957</udiDi>
    <basicUdiDi>B-10887714032957</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN226</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:32:57.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714032940</udiDi>
    <basicUdiDi>B-10887714032940</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN225</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:32:56.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714032933</udiDi>
    <basicUdiDi>B-10887714032933</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN224</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:32:56.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714032926</udiDi>
    <basicUdiDi>B-10887714032926</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN223</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:32:55.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714032919</udiDi>
    <basicUdiDi>B-10887714032919</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN222</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:32:51.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714032902</udiDi>
    <basicUdiDi>B-10887714032902</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN221</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:32:50.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714032896</udiDi>
    <basicUdiDi>B-10887714032896</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:32:49.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714032889</udiDi>
    <basicUdiDi>B-10887714032889</basicUdiDi>
    <tradeName>NUCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN219</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:32:48.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714032872</udiDi>
    <basicUdiDi>B-10887714032872</basicUdiDi>
    <tradeName>NuCLEUS</tradeName>
    <deviceName>NuCLEUS</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>PVN218</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:32:43.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020862</udiDi>
    <basicUdiDi>B-10887714020862</basicUdiDi>
    <tradeName>Z-MED II</tradeName>
    <deviceName>Z-MED II</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>PDZ686</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:32.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020848</udiDi>
    <basicUdiDi>B-10887714020848</basicUdiDi>
    <tradeName>Z-MED II</tradeName>
    <deviceName>Z-MED II</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>PDZ685</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:28.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020824</udiDi>
    <basicUdiDi>B-10887714020824</basicUdiDi>
    <tradeName>Z-MED II</tradeName>
    <deviceName>Z-MED II</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>PDZ684</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:27.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020800</udiDi>
    <basicUdiDi>B-10887714020800</basicUdiDi>
    <tradeName>Z-MED II</tradeName>
    <deviceName>Z-MED II</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>PDZ683</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:26.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020787</udiDi>
    <basicUdiDi>B-10887714020787</basicUdiDi>
    <tradeName>Z-MED II</tradeName>
    <deviceName>Z-MED II</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>PDZ682</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:25.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020763</udiDi>
    <basicUdiDi>B-10887714020763</basicUdiDi>
    <tradeName>Tyshak NuCLEUS</tradeName>
    <deviceName>Tyshak NuCLEUS</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>TN037</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:21.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020756</udiDi>
    <basicUdiDi>B-10887714020756</basicUdiDi>
    <tradeName>Tyshak NuCLEUS</tradeName>
    <deviceName>Tyshak NuCLEUS</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>TN036</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:21.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020749</udiDi>
    <basicUdiDi>B-10887714020749</basicUdiDi>
    <tradeName>Tyshak NuCLEUS</tradeName>
    <deviceName>Tyshak NuCLEUS</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>TN035</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:19.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020732</udiDi>
    <basicUdiDi>B-10887714020732</basicUdiDi>
    <tradeName>Tyshak NuCLEUS</tradeName>
    <deviceName>Tyshak NuCLEUS</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>TN034</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:18.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>10887714020725</udiDi>
    <basicUdiDi>B-10887714020725</basicUdiDi>
    <tradeName>Tyshak NuCLEUS</tradeName>
    <deviceName>Tyshak NuCLEUS</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>TN033</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:26:14.653Z</lastUpdated>
  </row>
</eudamedExport>