<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07540184010318</udiDi>
    <basicUdiDi>B-07540184010318</basicUdiDi>
    <tradeName>07540184010318</tradeName>
    <deviceName>OptoWire III Pressure Guidewire</deviceName>
    <manufacturerName>Opsens Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000018361</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F1031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:42.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540184010110</udiDi>
    <basicUdiDi>B-07540184010110</basicUdiDi>
    <tradeName>07540184010110</tradeName>
    <deviceName>OptoWire Deux Pressure Guidewire with Gauge Connector</deviceName>
    <manufacturerName>Opsens Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000018361</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04010101</emdnCode>
    <emdnDescription>CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F1011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:36.354Z</lastUpdated>
  </row>
</eudamedExport>