<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08437025957002</udiDi>
    <basicUdiDi>8437025957BGSG85</basicUdiDi>
    <tradeName>SMARTGAZE ORA</tradeName>
    <deviceName>SMARTGAZE ORA</deviceName>
    <manufacturerName>Biel Glasses S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000034333</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIEL SMARTGAZE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T13:42:26.647Z</lastUpdated>
  </row>
</eudamedExport>