<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-0821329OPTISEAL846J</udiDi>
    <basicUdiDi>B-0821329OPTISEAL846J</basicUdiDi>
    <tradeName>OptiSeal™ Valved Peelable PTFE Introducer Kit</tradeName>
    <deviceName>OptiSeal™ Valved Peelable PTFE Introducer Kit</deviceName>
    <manufacturerName>Greatbatch Medical</manufacturerName>
    <manufacturerSrn>US-MF-000032810</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000092-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-20T23:04:28.868Z</lastUpdated>
  </row>
</eudamedExport>