<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08888893018645</udiDi>
    <basicUdiDi>8888893BMX6HV</basicUdiDi>
    <tradeName>BioMatrix Alpha Drug Eluting Coronary Stent System</tradeName>
    <deviceName>BioMatrix Alpha Drug Eluting Coronary Stent System</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070402010301</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMX6-2209</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:12:03.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931473304439</udiDi>
    <basicUdiDi>69314733LP01QL</basicUdiDi>
    <tradeName>LaaGuarder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Shenqi Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013667</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040399</emdnCode>
    <emdnDescription>HEART AND CORONARY DEFECT OCCLUDERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP0121</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:49:45.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206220977</udiDi>
    <basicUdiDi>5413206UMTCS</basicUdiDi>
    <tradeName>Ultimaster Tansei</tradeName>
    <deviceName>Ultimaster Tansei Sirolimus eluting coronary stent system</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070402010301</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-RQ2515KSM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:00:19.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206220953</udiDi>
    <basicUdiDi>5413206UMTCS</basicUdiDi>
    <tradeName>Ultimaster Tansei</tradeName>
    <deviceName>Ultimaster Tansei Sirolimus eluting coronary stent system</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070402010301</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-RQ2512KSM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:52:21.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065021834107</udiDi>
    <basicUdiDi>5065021834SYNPP010Z2</basicUdiDi>
    <tradeName>Vascular Surgery</tradeName>
    <deviceName>VAS (Vascular Surgery)</deviceName>
    <manufacturerName>SYNDEO Medical</manufacturerName>
    <manufacturerSrn>BE-PR-000044136</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0704020299</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR STENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYN-VAS02-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:17:18.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260182525395</udiDi>
    <basicUdiDi>426018252MVSDPPD5</basicUdiDi>
    <tradeName>Occlutech mVSD Occluder Procedure Pack</tradeName>
    <deviceName>Occlutech mVSD Occluder Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040301</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>71VSD04P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:41:21.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260182525371</udiDi>
    <basicUdiDi>426018252MVSDFLEXII9X</basicUdiDi>
    <tradeName>Occlutech mVSD Occluder Procedure Pack</tradeName>
    <deviceName>Occlutech mVSD Occluder Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040301</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>71VSD04F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:41:20.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260182523063</udiDi>
    <basicUdiDi>426018252PLDFLEXIRC</basicUdiDi>
    <tradeName>Occlutech Paravalvular Leak Device Procedure Pack</tradeName>
    <deviceName>Occlutech Paravalvular Leak Device Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040399</emdnCode>
    <emdnDescription>HEART AND CORONARY DEFECT OCCLUDERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60PLD05WF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:41:00.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260182523032</udiDi>
    <basicUdiDi>426018252PLDPP78</basicUdiDi>
    <tradeName>Occlutech Paravalvular Leak Device Procedure Pack</tradeName>
    <deviceName>Occlutech Paravalvular Leak Device Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040399</emdnCode>
    <emdnDescription>HEART AND CORONARY DEFECT OCCLUDERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60PLD04WP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:40:59.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255888902915</udiDi>
    <basicUdiDi>426018252PDAOOP5U</basicUdiDi>
    <tradeName>Occlutech PDA Occluder Procedure Pack</tradeName>
    <deviceName>Occlutech PDA Occluder Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040303</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42PDA05O</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:41.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255888901116</udiDi>
    <basicUdiDi>426018252ASDIIPP9A</basicUdiDi>
    <tradeName>Figulla Flex II ASD Occluder Procedure Pack</tradeName>
    <deviceName>Figulla Flex II ASD Occluder Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040302</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29ASD04P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:40.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255888901086</udiDi>
    <basicUdiDi>426018252ASDIIFLEXIIF6</basicUdiDi>
    <tradeName>Figulla Flex II ASD Occluder Procedure Pack</tradeName>
    <deviceName>Figulla Flex II ASD Occluder Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040302</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29ASD04F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:36.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255888900331</udiDi>
    <basicUdiDi>426018252PFOIIIPPTB</basicUdiDi>
    <tradeName>Figulla® Flex II PFO Occluder Procedure Pack</tradeName>
    <deviceName>Figulla Flex II PFO Occluder Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040303</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18PFO25SP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:36.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255888900317</udiDi>
    <basicUdiDi>426018252PFOIIIFLEXIIRS</basicUdiDi>
    <tradeName>Figulla Flex II PFO Occluder Procedure Pack</tradeName>
    <deviceName>Figulla Flex II PFO Occluder Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040303</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18PFO25SF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:35.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255888900034</udiDi>
    <basicUdiDi>426018252UNIIIPPKL</basicUdiDi>
    <tradeName>Figulla Flex II UNI Occluder Procedure Pack</tradeName>
    <deviceName>Figulla Flex II UNI Occluder Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040302</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16UNI17P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:34.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255888900010</udiDi>
    <basicUdiDi>426018252UNIIIFLEXIIZL</basicUdiDi>
    <tradeName>Figulla Flex II UNI Occluder Procedure Pack</tradeName>
    <deviceName>Figulla Flex II UNI Occluder Procedure Pack</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000049872</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040302</emdnCode>
    <emdnDescription>CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16UNI17F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:30.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260123784645</udiDi>
    <basicUdiDi>426012378NeuroStentTE</basicUdiDi>
    <tradeName>pEGASUS Stent System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>phenox GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006524</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEGASUS-350-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:31:13.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260123784225</udiDi>
    <basicUdiDi>426012378BifurImplantGK</basicUdiDi>
    <tradeName>pCONUS2 Bifurcation Aneurysm Implant</tradeName>
    <deviceName></deviceName>
    <manufacturerName>phenox GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006524</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCON2-4-15-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:31:09.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260123783198</udiDi>
    <basicUdiDi>426012378FlowDiverterSV</basicUdiDi>
    <tradeName>p64 Flow Modulation Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>phenox GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006524</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>p64-250-9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:31:07.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817508012790</udiDi>
    <basicUdiDi>081750801DynamXVIR4F</basicUdiDi>
    <tradeName>DynamX Sirolimus Eluting Coronary Bioadaptor System</tradeName>
    <deviceName>DynamX Sirolimus Eluting Coronary Bioadaptor System</deviceName>
    <manufacturerName>Elixir Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000013041</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07040199</emdnCode>
    <emdnDescription>VASCULAR ENDOPROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIR2214</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:58:17.197Z</lastUpdated>
  </row>
</eudamedExport>