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    <tradeName>Starkey Omega AI  20 ITE R</tradeName>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>72145-SHT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.594Z</lastUpdated>
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    <tradeName>Starkey Omega AI  16 ITE R</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>HEARING AID IN THE-EAR (ITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72146-SHT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.568Z</lastUpdated>
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    <udiDi>00840388210215</udiDi>
    <basicUdiDi>0842318172153UZ</basicUdiDi>
    <tradeName>Starkey Omega AI 20 HS R</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>HEARING AIDS IN-THE-CANAL (ITC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72151-SHT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.541Z</lastUpdated>
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    <tradeName>Starkey Omega AI 16 HS R</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>HEARING AIDS IN-THE-CANAL (ITC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72152-SHT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.521Z</lastUpdated>
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    <udiDi>00840388210246</udiDi>
    <basicUdiDi>0842318172153UZ</basicUdiDi>
    <tradeName>OuieZen 16 OM CIC</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>HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72155-OPT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.492Z</lastUpdated>
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    <udiDi>00840388210277</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>Audibel Aris AI 24 mRIC R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63391-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.470Z</lastUpdated>
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    <udiDi>00840388210284</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>Audibel Aris AI 20 mRIC R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63392-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.448Z</lastUpdated>
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    <udiDi>00840388210307</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>Audibel Aris AI 16 mRIC R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63393-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.427Z</lastUpdated>
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    <udiDi>00840388210321</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>NuEar Noble AI 24 mRIC R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63391-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.398Z</lastUpdated>
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    <udiDi>00840388210338</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>NuEar Noble AI 20 mRIC R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63392-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.382Z</lastUpdated>
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    <udiDi>00840388210345</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>NuEar Noble AI 16 mRIC R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63393-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.355Z</lastUpdated>
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    <udiDi>00840388210406</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>AMPLI-MINI E 5|7S RITE-R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63391-U</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.340Z</lastUpdated>
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    <udiDi>00840388210413</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>AMPLI-MINI E 4|7S RITE-R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63392-U</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.328Z</lastUpdated>
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    <udiDi>00840388210420</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>AMPLI-MINI E 3|7S RITE-R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63393-U</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.303Z</lastUpdated>
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    <udiDi>00840388210505</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>OuïeZen 16 OM mRIC R</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63393-K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.288Z</lastUpdated>
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    <udiDi>00840388210512</udiDi>
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    <tradeName>Incognito OM AI 24 mRIC</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63391-F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.272Z</lastUpdated>
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    <udiDi>00840388210529</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>Incognito OM AI 16 mRIC</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63393-F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.257Z</lastUpdated>
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    <udiDi>00840388210550</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>Audibel Aris AI 24 RIC 312</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63413-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.224Z</lastUpdated>
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    <udiDi>00840388210567</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>Audibel Aris AI Cros RIC 312</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63414-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.208Z</lastUpdated>
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    <udiDi>00840388210574</udiDi>
    <basicUdiDi>0842318163381VC</basicUdiDi>
    <tradeName>Audibel Aris AI 20 RIC 312</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 CANAL (RIC, RITE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63415-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:49:39.192Z</lastUpdated>
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