<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00389701009513</udiDi>
    <basicUdiDi>B-00389701009513</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*B4SK06MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:28.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009483</udiDi>
    <basicUdiDi>B-00389701009483</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C4SK06NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:27.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009506</udiDi>
    <basicUdiDi>B-00389701009506</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C4SK25NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:26.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009490</udiDi>
    <basicUdiDi>B-00389701009490</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C4SK10NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:24.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009421</udiDi>
    <basicUdiDi>B-00389701009421</basicUdiDi>
    <tradeName>Destination Peripheral Guiding Sheath</tradeName>
    <deviceName>Guiding Sheaths</deviceName>
    <manufacturerName>Terumo Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026109</manufacturerSrn>
    <authorisedRepresentativeName>TERUMO EUROPE N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001433</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54-84506</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:21.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701008868</udiDi>
    <basicUdiDi>B-00389701008868</basicUdiDi>
    <tradeName>Destination Peripheral Guiding Sheath</tradeName>
    <deviceName>Guiding Sheaths</deviceName>
    <manufacturerName>Terumo Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026109</manufacturerSrn>
    <authorisedRepresentativeName>TERUMO EUROPE N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001433</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54-74506</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:07.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701008844</udiDi>
    <basicUdiDi>B-00389701008844</basicUdiDi>
    <tradeName>Destination Peripheral Guiding Sheath</tradeName>
    <deviceName>Guiding Sheaths</deviceName>
    <manufacturerName>Terumo Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026109</manufacturerSrn>
    <authorisedRepresentativeName>TERUMO EUROPE N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001433</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54-64506</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:05.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005584</udiDi>
    <basicUdiDi>B-00389701005584</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C8SN25NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:04.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005577</udiDi>
    <basicUdiDi>B-00389701005577</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C7SN25NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:03.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005560</udiDi>
    <basicUdiDi>B-00389701005560</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C6SN25NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:00.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005553</udiDi>
    <basicUdiDi>B-00389701005553</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C8SN10NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:58.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005546</udiDi>
    <basicUdiDi>B-00389701005546</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C7SN10NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:57.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005539</udiDi>
    <basicUdiDi>B-00389701005539</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C6SN10NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:55.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005515</udiDi>
    <basicUdiDi>B-00389701005515</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C7SN06NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:53.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005508</udiDi>
    <basicUdiDi>B-00389701005508</basicUdiDi>
    <tradeName>RADIFOCUS INTRODUCER II with R/O MARKER</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>RB*C6SN06NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:51.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005423</udiDi>
    <basicUdiDi>B-00389701005423</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*B11N10MRD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:50.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005416</udiDi>
    <basicUdiDi>B-00389701005416</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*B10N10MRD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:48.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005409</udiDi>
    <basicUdiDi>B-00389701005409</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*B90N10MRD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:46.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005393</udiDi>
    <basicUdiDi>B-00389701005393</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*B80N10MRD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:44.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701005386</udiDi>
    <basicUdiDi>B-00389701005386</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*B70N10MRD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:45:43.028Z</lastUpdated>
  </row>
</eudamedExport>