<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00817020029924</udiDi>
    <basicUdiDi>B-00817020029924</basicUdiDi>
    <tradeName>MADSEN Capella2</tradeName>
    <deviceName>MADSEN Capella2</deviceName>
    <manufacturerName>Intelligent Hearing Systems Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000011473</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12149001</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-04-15320</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:03:44.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817020020075</udiDi>
    <basicUdiDi>08172002M010300EP</basicUdiDi>
    <tradeName>USB Jr Duet</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12149001</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:09:24.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817020020037</udiDi>
    <basicUdiDi>08172002M013910GD</basicUdiDi>
    <tradeName>Lilly TM-Wick Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Intelligent Hearing Systems Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000011473</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N01010299</emdnCode>
    <emdnDescription>EEG ELECTRODES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:09:23.190Z</lastUpdated>
  </row>
</eudamedExport>