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    <lastUpdated>2026-07-16T06:21:46.393Z</lastUpdated>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <deviceName>ITE KIT Family</deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D01 - 07010101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>04262451170046</udiDi>
    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>BTE Family</deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:33:54.470Z</lastUpdated>
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    <udiDi>04262451170022</udiDi>
    <basicUdiDi>426245117ITE17Z</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>ITE Family</deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BOX HEARING AIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>126D01-02270171</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:33:52.757Z</lastUpdated>
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    <udiDi>04262451170008</udiDi>
    <basicUdiDi>426245117TIE18P</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName>TIE Family</deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128D02-02290184</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:33:51.967Z</lastUpdated>
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    <udiDi>04262451170015</udiDi>
    <basicUdiDi>426245117TIE18P</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128D02-02290187</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:47.047Z</lastUpdated>
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    <udiDi>04262451170077</udiDi>
    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.949Z</lastUpdated>
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    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.930Z</lastUpdated>
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    <udiDi>04262451170091</udiDi>
    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.912Z</lastUpdated>
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    <udiDi>04262451170107</udiDi>
    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.887Z</lastUpdated>
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    <udiDi>04262451170114</udiDi>
    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.855Z</lastUpdated>
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    <udiDi>04262451170121</udiDi>
    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010123</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.833Z</lastUpdated>
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    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010124</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.812Z</lastUpdated>
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    <udiDi>04262451170145</udiDi>
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    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.793Z</lastUpdated>
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    <udiDi>04262451170152</udiDi>
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    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010132</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.772Z</lastUpdated>
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    <tradeName>Helix</tradeName>
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    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010133</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.753Z</lastUpdated>
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    <basicUdiDi>426245117BTE16G</basicUdiDi>
    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160D02 - 07010134</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.733Z</lastUpdated>
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    <tradeName>Helix</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ear-Technic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043916</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>133D01-02330198</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T08:06:46.715Z</lastUpdated>
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