<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00818009011381</udiDi>
    <basicUdiDi>B-00818009011381</basicUdiDi>
    <tradeName>AFX Introducer</tradeName>
    <deviceName>AFX Introducer System</deviceName>
    <manufacturerName>Endologix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010201</manufacturerSrn>
    <authorisedRepresentativeName>Endologix International Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006044</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00511</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:18.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810087180072</udiDi>
    <basicUdiDi>B-00810087180072</basicUdiDi>
    <tradeName>FARADRIVE™</tradeName>
    <deviceName>FARADRIVE Steerable Sheath (clear)</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21M402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:39:18.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810024670048</udiDi>
    <basicUdiDi>B-00810024670048</basicUdiDi>
    <tradeName>SSPC Delivery Catheter</tradeName>
    <deviceName>SSPC Delivery Catheter</deviceName>
    <manufacturerName>CenterPoint Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000009054</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9184</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:23:09.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810024670031</udiDi>
    <basicUdiDi>B-00810024670031</basicUdiDi>
    <tradeName>SSPC Delivery Catheter</tradeName>
    <deviceName>SSPC Delivery Catheter</deviceName>
    <manufacturerName>CenterPoint Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000009054</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9183</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:23:08.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810024670024</udiDi>
    <basicUdiDi>B-00810024670024</basicUdiDi>
    <tradeName>SSPC Delivery Catheter</tradeName>
    <deviceName>SSPC Delivery Catheter</deviceName>
    <manufacturerName>CenterPoint Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000009054</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9182</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:23:04.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810024670017</udiDi>
    <basicUdiDi>B-00810024670017</basicUdiDi>
    <tradeName>SSPC Delivery Catheter</tradeName>
    <deviceName>SSPC Delivery Catheter</deviceName>
    <manufacturerName>CenterPoint Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000009054</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9181</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:23:04.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982118F21221</udiDi>
    <basicUdiDi>B-+B827982118F21221</basicUdiDi>
    <tradeName>+B827982118F21221</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982118F2122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:16.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982117F21421</udiDi>
    <basicUdiDi>B-+B827982117F21421</basicUdiDi>
    <tradeName>+B827982117F21421</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982117F2142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:15.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982117F21221</udiDi>
    <basicUdiDi>B-+B827982117F21221</basicUdiDi>
    <tradeName>+B827982117F21221</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982117F2122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:12.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982116R52341</udiDi>
    <basicUdiDi>B-+B827982116R52341</basicUdiDi>
    <tradeName>+B827982116R52341</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982116R5234</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:11.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982116R51341</udiDi>
    <basicUdiDi>B-+B827982116R51341</basicUdiDi>
    <tradeName>+B827982116R51341</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982116R5134</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:10.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982116R51111</udiDi>
    <basicUdiDi>B-+B827982116R51111</basicUdiDi>
    <tradeName>+B827982116R51111</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982116R5111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:08.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982116R32111</udiDi>
    <basicUdiDi>B-+B827982116R32111</basicUdiDi>
    <tradeName>+B827982116R32111</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982116R3211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:06.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982116R21111</udiDi>
    <basicUdiDi>B-+B827982116R21111</basicUdiDi>
    <tradeName>+B827982116R21111</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982116R2111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:04.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982116R14111</udiDi>
    <basicUdiDi>B-+B827982116R14111</basicUdiDi>
    <tradeName>+B827982116R14111</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982116R1411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:04.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982116F21421</udiDi>
    <basicUdiDi>B-+B827982116F21421</basicUdiDi>
    <tradeName>+B827982116F21421</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982116F2142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:02.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982116F21221</udiDi>
    <basicUdiDi>B-+B827982116F21221</basicUdiDi>
    <tradeName>+B827982116F21221</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982116F2122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:30:00.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982115R52341</udiDi>
    <basicUdiDi>B-+B827982115R52341</basicUdiDi>
    <tradeName>+B827982115R52341</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982115R5234</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:29:58.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982115R52111</udiDi>
    <basicUdiDi>B-+B827982115R52111</basicUdiDi>
    <tradeName>+B827982115R52111</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982115R5211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:29:57.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B827982115R51341</udiDi>
    <basicUdiDi>B-+B827982115R51341</basicUdiDi>
    <tradeName>+B827982115R51341</tradeName>
    <deviceName>MedK Introducer Sets</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>982115R5134</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:29:56.029Z</lastUpdated>
  </row>
</eudamedExport>