<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00389701005379</udiDi>
    <basicUdiDi>B-00389701005379</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II</tradeName>
    <deviceName>INTRODUCER KIT</deviceName>
    <manufacturerName>Terumo Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026109</manufacturerSrn>
    <authorisedRepresentativeName>TERUMO EUROPE N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001433</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS*B60N10MRD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:41.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005362</udiDi>
    <basicUdiDi>B-00389701005362</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II</tradeName>
    <deviceName>INTRODUCER KIT</deviceName>
    <manufacturerName>Terumo Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026109</manufacturerSrn>
    <authorisedRepresentativeName>TERUMO EUROPE N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001433</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS*B50N10MRD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:39.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005355</udiDi>
    <basicUdiDi>B-00389701005355</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II</tradeName>
    <deviceName>INTRODUCER KIT</deviceName>
    <manufacturerName>Terumo Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026109</manufacturerSrn>
    <authorisedRepresentativeName>TERUMO EUROPE N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001433</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS*B40K10MR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:37.428Z</lastUpdated>
  </row>
</eudamedExport>