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    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
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    <authorisedRepresentativeSrn>DE-AR-000010831</authorisedRepresentativeSrn>
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    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
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    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
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    <tradeName>OuïeZen 12 GS BTE 13 UP</tradeName>
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    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
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    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
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    <tradeName>Incognito GS 12 BTE 13 UP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-30T09:49:38.050Z</lastUpdated>
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    <udiDi>00840388212301</udiDi>
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    <tradeName>Starkey G Series AI 24 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63420-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00840388212318</udiDi>
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    <tradeName>Starkey G Series AI 20 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63421-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>Starkey G Series AI 16 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63422-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <basicUdiDi>0842318163400UP</basicUdiDi>
    <tradeName>Starkey G Series AI 12 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63423-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:37.991Z</lastUpdated>
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    <basicUdiDi>0842318163400UP</basicUdiDi>
    <tradeName>Starkey G Series AI 10 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63424-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:37.979Z</lastUpdated>
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    <tradeName>Audibel A Series AI 24 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63420-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:37.962Z</lastUpdated>
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    <basicUdiDi>0842318163400UP</basicUdiDi>
    <tradeName>Audibel A Series AI 20 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63421-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:37.945Z</lastUpdated>
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    <udiDi>00840388212424</udiDi>
    <basicUdiDi>0842318163400UP</basicUdiDi>
    <tradeName>Audibel A Series AI 16 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63422-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:37.930Z</lastUpdated>
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    <tradeName>Audibel A Series AI 12 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63423-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014382</manufacturerSrn>
    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63424-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>NuEar NE Series AI 24 P BTE 13</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
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    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
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    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63420-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
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    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63421-4</reference>
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    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)</emdnDescription>
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    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
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    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63424-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <deviceName></deviceName>
    <manufacturerName>Starkey Laboratories Inc.</manufacturerName>
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    <authorisedRepresentativeName>Starkey Laboratories (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010831</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>63422-U</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:37.726Z</lastUpdated>
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