<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719961300017</udiDi>
    <basicUdiDi>471996130OPALHK4</basicUdiDi>
    <tradeName>OPAL</tradeName>
    <deviceName>“Inti” Oocyte Holding Device (Non-Sterile)</deviceName>
    <manufacturerName>Inti Taiwan, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000048831</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPAL H1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:33:43.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719961300048</udiDi>
    <basicUdiDi>471996130OPALHK4</basicUdiDi>
    <tradeName>Opal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inti Taiwan, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000048831</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Opal H2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T03:51:53.229Z</lastUpdated>
  </row>
</eudamedExport>