<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00389701006246</udiDi>
    <basicUdiDi>B-00389701006246</basicUdiDi>
    <tradeName>Destination Renal Guiding Sheath</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSR09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:42:17.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701006253</udiDi>
    <basicUdiDi>B-00389701006253</basicUdiDi>
    <tradeName>Destination Renal Guiding Sheath</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSR10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:42:17.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701006260</udiDi>
    <basicUdiDi>B-00389701006260</basicUdiDi>
    <tradeName>Destination Renal Guiding Sheath</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSR11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:42:17.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009681</udiDi>
    <basicUdiDi>B-00389701009681</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*B9SN10MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:59.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009674</udiDi>
    <basicUdiDi>B-00389701009674</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*B9SN06MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:56.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009667</udiDi>
    <basicUdiDi>B-00389701009667</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*C9SN25NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:55.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009650</udiDi>
    <basicUdiDi>B-00389701009650</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*C9SN10NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:54.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009643</udiDi>
    <basicUdiDi>B-00389701009643</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*C9SN06NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:52.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009636</udiDi>
    <basicUdiDi>B-00389701009636</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*B8SN10MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:50.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009629</udiDi>
    <basicUdiDi>B-00389701009629</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*B8SN06MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:47.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009612</udiDi>
    <basicUdiDi>B-00389701009612</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*B7SN10MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:47.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009605</udiDi>
    <basicUdiDi>B-00389701009605</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*B7SN06MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:45.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009599</udiDi>
    <basicUdiDi>B-00389701009599</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*B6SN10MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:43.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009582</udiDi>
    <basicUdiDi>B-00389701009582</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*B6SN06MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:41.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009575</udiDi>
    <basicUdiDi>B-00389701009575</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*B5SN10MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:40.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009568</udiDi>
    <basicUdiDi>B-00389701009568</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*B5SN06MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:38.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009551</udiDi>
    <basicUdiDi>B-00389701009551</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*C5SN25NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:35.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009544</udiDi>
    <basicUdiDi>B-00389701009544</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*C5SN10NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:34.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009537</udiDi>
    <basicUdiDi>B-00389701009537</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*C5SN06NC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:33.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>00389701009520</udiDi>
    <basicUdiDi>B-00389701009520</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*B4SK10MC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:46:32.196Z</lastUpdated>
  </row>
</eudamedExport>