<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08606113110005</udiDi>
    <basicUdiDi>8606113110LensesSH</basicUdiDi>
    <tradeName>08606113110005</tradeName>
    <deviceName>prescription ophtalmic lenses</deviceName>
    <manufacturerName>SANI GROUP d.o.o.</manufacturerName>
    <manufacturerSrn>RS-MF-000048277</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>clear indeks 1.5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:08:43.206Z</lastUpdated>
  </row>
</eudamedExport>