<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00817020020075</udiDi>
    <basicUdiDi>08172002M010300EP</basicUdiDi>
    <tradeName>USB Jr Duet</tradeName>
    <deviceName>USB Jr Duet</deviceName>
    <manufacturerName>Intelligent Hearing Systems Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000011473</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149001</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M010300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:26:41.818Z</lastUpdated>
  </row>
</eudamedExport>