<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00763000758646</udiDi>
    <basicUdiDi>0763000B000226786</basicUdiDi>
    <tradeName>Confida™</tradeName>
    <deviceName>Confida™  Brecker Guidewire</deviceName>
    <manufacturerName>Medtronic CoreValve LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019985</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GWBC30</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-25T01:29:56.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255605608205</udiDi>
    <basicUdiDi>42556056gwcIIIEH</basicUdiDi>
    <tradeName>04255605608205</tradeName>
    <deviceName>Guidewires for Central Circulatory Application</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44013524</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:44:30.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255605608229</udiDi>
    <basicUdiDi>42556056gwcIIIEH</basicUdiDi>
    <tradeName>04255605608229</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49012949</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:38:20.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>04255605600681</udiDi>
    <basicUdiDi>42556056gwcIIIEH</basicUdiDi>
    <tradeName>04255605600681</tradeName>
    <deviceName>Guidewires for Central Circulatory Application</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA-035-260-30A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:14:53.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GWT.028-180-TH-DHMY2</udiDi>
    <basicUdiDi>B-GWT.028-180-TH-DHMY2</basicUdiDi>
    <tradeName>D-GWT.028-180-TH-DHMY2</tradeName>
    <deviceName>Führungsdraht 028/180cm</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GWT.028-180-TH-DHM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:43:45.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GW480-035NJ</udiDi>
    <basicUdiDi>B-GW480-035NJ</basicUdiDi>
    <tradeName>D-GW480-035NJ</tradeName>
    <deviceName>Gudewire 50mm Radiopaque tip</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW480-035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:43:44.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GW260-035LN</udiDi>
    <basicUdiDi>B-GW260-035LN</basicUdiDi>
    <tradeName>D-GW260-035LN</tradeName>
    <deviceName>guidewire radiopaque tip</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW260-035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:43:43.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-49012948BM</udiDi>
    <basicUdiDi>B-49012948BM</basicUdiDi>
    <tradeName>D-49012948BM</tradeName>
    <deviceName>PTFE Guidewire J3-tip</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49012948</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:18:09.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-49012896BT</udiDi>
    <basicUdiDi>B-49012896BT</basicUdiDi>
    <tradeName>D-49012896BT</tradeName>
    <deviceName>MR-Guide-MS2 SFCPH-180/14-025</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49012896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:18:08.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-49012876BM</udiDi>
    <basicUdiDi>B-49012876BM</basicUdiDi>
    <tradeName>D-49012876BM</tradeName>
    <deviceName>MR-Guide R2 AFCPH-260/14-035</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49012876</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:18:07.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-49012872BD</udiDi>
    <basicUdiDi>B-49012872BD</basicUdiDi>
    <tradeName>D-49012872BD</tradeName>
    <deviceName>MR-Guide R2 SFCPH-180-035</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49012872</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:18:07.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-49012797BQ</udiDi>
    <basicUdiDi>B-49012797BQ</basicUdiDi>
    <tradeName>D-49012797BQ</tradeName>
    <deviceName>Guidewire J40-FC-270-035/So/PTFE-T</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49012797</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:18:03.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-49012796BN</udiDi>
    <basicUdiDi>B-49012796BN</basicUdiDi>
    <tradeName>D-49012796BN</tradeName>
    <deviceName>Guidewire J30-FC-270-035/So./PTFE-T</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49012796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:18:02.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-49012726AZ</udiDi>
    <basicUdiDi>B-49012726AZ</basicUdiDi>
    <tradeName>D-49012726AZ</tradeName>
    <deviceName>Guidewire J10-FC-220/18-035/PTFE</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49012726</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:18:01.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-48012481A9</udiDi>
    <basicUdiDi>B-48012481A9</basicUdiDi>
    <tradeName>D-48012481A9</tradeName>
    <deviceName>Andraguide .035 flex 15 260 J6</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48012481</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:25.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-48012480A7</udiDi>
    <basicUdiDi>B-48012480A7</basicUdiDi>
    <tradeName>D-48012480A7</tradeName>
    <deviceName>AndraGuide .035 flex 15 260 J3</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48012480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:23.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-48012479AN</udiDi>
    <basicUdiDi>B-48012479AN</basicUdiDi>
    <tradeName>D-48012479AN</tradeName>
    <deviceName>Andraguide .035 flex 15 260 straight</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48012479</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:21.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-48012475AE</udiDi>
    <basicUdiDi>B-48012475AE</basicUdiDi>
    <tradeName>D-48012475AE</tradeName>
    <deviceName>Guidewire J6-FC-260/10M-035</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48012475</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:20.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-48012473AA</udiDi>
    <basicUdiDi>B-48012473AA</basicUdiDi>
    <tradeName>D-48012473AA</tradeName>
    <deviceName>AndraGuide .035 flex 10M 260</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48012473</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:19.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-48012469AK</udiDi>
    <basicUdiDi>B-48012469AK</basicUdiDi>
    <tradeName>D-48012469AK</tradeName>
    <deviceName>AndraGuide .035 flex 5 260 J6</deviceName>
    <manufacturerName>EPflex Feinwerktechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005425</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0499</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48012469</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:16.672Z</lastUpdated>
  </row>
</eudamedExport>