<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08682549131234</udiDi>
    <basicUdiDi>B-08682549131234</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060203</emdnCode>
    <emdnDescription>HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>142-02350101</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:37.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131227</udiDi>
    <basicUdiDi>B-08682549131227</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>134-02340163</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:35.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131210</udiDi>
    <basicUdiDi>B-08682549131210</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060204</emdnCode>
    <emdnDescription>HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146-02400186</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:33.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131203</udiDi>
    <basicUdiDi>B-08682549131203</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060203</emdnCode>
    <emdnDescription>HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>134-02340192</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:31.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131197</udiDi>
    <basicUdiDi>B-08682549131197</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060203</emdnCode>
    <emdnDescription>HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>134-02340101</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:31.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131180</udiDi>
    <basicUdiDi>B-08682549131180</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>133-02330163</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:29.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131159</udiDi>
    <basicUdiDi>B-08682549131159</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060203</emdnCode>
    <emdnDescription>HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>133-02330101</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:27.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131173</udiDi>
    <basicUdiDi>B-08682549131173</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060204</emdnCode>
    <emdnDescription>HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146-02400186</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:24.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131166</udiDi>
    <basicUdiDi>B-08682549131166</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060203</emdnCode>
    <emdnDescription>HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>133-02330192</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:24.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131142</udiDi>
    <basicUdiDi>B-08682549131142</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>BTE Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146-02400180</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:10.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131135</udiDi>
    <basicUdiDi>B-08682549131135</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITE Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y21450603</emdnCode>
    <emdnDescription>BOX HEARING AIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146-02400171</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:06.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131128</udiDi>
    <basicUdiDi>B-08682549131128</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITE Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y21450603</emdnCode>
    <emdnDescription>BOX HEARING AIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146-02400171</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:05.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131111</udiDi>
    <basicUdiDi>B-08682549131111</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>BTE Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>145-02390173</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:04.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131104</udiDi>
    <basicUdiDi>B-08682549131104</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>BTE Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060102</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146-02400136</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:16:03.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131098</udiDi>
    <basicUdiDi>B-08682549131098</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146-02400163</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:15:59.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131081</udiDi>
    <basicUdiDi>B-08682549131081</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>BTE Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060101</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>145-02390170</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:15:59.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131074</udiDi>
    <basicUdiDi>B-08682549131074</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060203</emdnCode>
    <emdnDescription>HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146-02400192</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:15:58.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131050</udiDi>
    <basicUdiDi>B-08682549131050</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>BTE Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060102</emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08682549131050</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:15:56.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131043</udiDi>
    <basicUdiDi>B-08682549131043</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060201</emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>145-02390163</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:15:52.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682549131036</udiDi>
    <basicUdiDi>B-08682549131036</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITEKIT Family</deviceName>
    <manufacturerName>Ear Technic Hearing Aids</manufacturerName>
    <manufacturerSrn>TR-MF-000034630</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y2145060204</emdnCode>
    <emdnDescription>HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>145-02390186</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:15:51.840Z</lastUpdated>
  </row>
</eudamedExport>