<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-852071QT</udiDi>
    <basicUdiDi>B-852071QT</basicUdiDi>
    <tradeName>D-852071QT</tradeName>
    <deviceName>INTRODUTTORE/DILATATORE PEEL-AWAY 11F(13,5/17cm)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852071</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:18:07.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-852070QR</udiDi>
    <basicUdiDi>B-852070QR</basicUdiDi>
    <tradeName>D-852070QR</tradeName>
    <deviceName>INTRODUTTORE/DILATATORE PEEL-AWAY 10F(13,5/17cm)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852070</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:18:05.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-852069R8</udiDi>
    <basicUdiDi>B-852069R8</basicUdiDi>
    <tradeName>D-852069R8</tradeName>
    <deviceName>INTRODUTTORE/DILATATORE PEEL-AWAY 9F(13,5/17cm)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852069</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:18:03.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-852068R6</udiDi>
    <basicUdiDi>B-852068R6</basicUdiDi>
    <tradeName>D-852068R6</tradeName>
    <deviceName>INTRODUTTORE/DILATATORE PEEL-AWAY 8F(13,5/17cm)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852068</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:18:03.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-852066R2</udiDi>
    <basicUdiDi>B-852066R2</basicUdiDi>
    <tradeName>D-852066R2</tradeName>
    <deviceName>INTRODUTTORE/DILATATORE PEEL-AWAY 6F(13,5/17cm)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852066</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:18:01.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-852067R4</udiDi>
    <basicUdiDi>B-852067R4</basicUdiDi>
    <tradeName>D-852067R4</tradeName>
    <deviceName>INTRODUTTORE/DILATATORE PEEL-AWAY 7F(13,5/17cm)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852067</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:17:59.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700484501051</udiDi>
    <basicUdiDi>B-03700484501051</basicUdiDi>
    <tradeName>03700484501051</tradeName>
    <deviceName>Venous introducers</deviceName>
    <manufacturerName>ISOMED</manufacturerName>
    <manufacturerSrn>FR-MF-000018485</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>432005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:06:25.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884450251508</udiDi>
    <basicUdiDi>B-00884450251508</basicUdiDi>
    <tradeName>Prelude SNAP™</tradeName>
    <deviceName>Prelude SNAP™</deviceName>
    <manufacturerName>Merit Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001366</manufacturerSrn>
    <authorisedRepresentativeName>Merit Medical Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001011</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLS-1007</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:59:06.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002310001</udiDi>
    <basicUdiDi>B-00827002310001</basicUdiDi>
    <tradeName>Peel-Away®</tradeName>
    <deviceName>Peel-Away® Introducer Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVN-7.0-38-24-VAD5-CVI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:39:01.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002298415</udiDi>
    <basicUdiDi>B-00827002298415</basicUdiDi>
    <tradeName>Peel-Away®</tradeName>
    <deviceName>Peel-Away® Introducer Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVN-9.0-38-24-VAD5-CVI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:34:08.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002282322</udiDi>
    <basicUdiDi>B-00827002282322</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-17.0-38-15.5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:33:55.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002270053</udiDi>
    <basicUdiDi>B-00827002270053</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-16.0-38-13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:33:53.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002100688</udiDi>
    <basicUdiDi>B-00827002100688</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-20.0-38-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:24:52.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002090675</udiDi>
    <basicUdiDi>B-00827002090675</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-18.0-38-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:24:52.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002089716</udiDi>
    <basicUdiDi>B-00827002089716</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-22.0-38-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:24:51.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002087828</udiDi>
    <basicUdiDi>B-00827002087828</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-24.0-38-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:24:50.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002086920</udiDi>
    <basicUdiDi>B-00827002086920</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-15.0-38-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:24:46.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002085138</udiDi>
    <basicUdiDi>B-00827002085138</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-8.0-38-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:24:45.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002083813</udiDi>
    <basicUdiDi>B-00827002083813</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-7.0-38-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:24:44.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002083707</udiDi>
    <basicUdiDi>B-00827002083707</basicUdiDi>
    <tradeName>Silhouette® Peel-Away®</tradeName>
    <deviceName>Silhouette® Transitionless Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLVTW-15.0-38-15.5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:24:40.156Z</lastUpdated>
  </row>
</eudamedExport>