<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00842318186799</udiDi>
    <basicUdiDi>0842318163311UP</basicUdiDi>
    <tradeName>STARKEY EVOLV AI 1000 CIC NW</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>63326-SHT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318187147</udiDi>
    <basicUdiDi>0842318163311UP</basicUdiDi>
    <tradeName>STARKEY EVOLV AI 2400 IIC NW</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 INVISIBLE-IN-THE-CANAL (IIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63327-SHT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318187154</udiDi>
    <basicUdiDi>0842318163311UP</basicUdiDi>
    <tradeName>STARKEY EVOLV AI 2000 IIC NW</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 INVISIBLE-IN-THE-CANAL (IIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63328-SHT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318187161</udiDi>
    <basicUdiDi>0842318163311UP</basicUdiDi>
    <tradeName>STARKEY EVOLV AI 1600 IIC NW</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 INVISIBLE-IN-THE-CANAL (IIC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63329-SHT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318188991</udiDi>
    <basicUdiDi>0842318163276VE</basicUdiDi>
    <tradeName>Amplifon Ampli-Energy 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>63281</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318190376</udiDi>
    <basicUdiDi>0842318160516UN</basicUdiDi>
    <tradeName>Pro Fit Fitting Software</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>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60516-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318193490</udiDi>
    <basicUdiDi>0842318143084UD</basicUdiDi>
    <tradeName>Starkey Standard Charger</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43084</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318193506</udiDi>
    <basicUdiDi>0842318143084UD</basicUdiDi>
    <tradeName>Starkey Custom Charger</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HEARING AIDS OR HEARING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43085</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195012</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>Genesis AI 24 RIC RT</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>63191-1XX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195029</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>Genesis AI CROS RIC RT</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>63332-1XX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195036</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>Genesis AI 20 RIC RT</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>63316-1XX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195043</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>Genesis AI 16 RIC RT</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>63317-1XX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195050</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>Genesis AI 12 RIC RT</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>63318-1XX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195067</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>AUDIBEL INTRIGUE AI 24 RIC RT</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>63191-223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195074</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>AUDIBEL INTRIGUE AI CROS RIC RT</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>63332-223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195081</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>AUDIBEL INTRIGUE AI 20 RIC RT</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>63316-223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195098</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>AUDIBEL INTRIGUE AI 16 RIC RT</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>63317-223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195104</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>AUDIBEL INTRIGUE AI 12 RIC RT</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>63318-223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195111</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>NUEAR NE NXG AI 24 RIC RT</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>63191-423</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842318195128</udiDi>
    <basicUdiDi>0842318163191V5</basicUdiDi>
    <tradeName>NUEAR NE NXG AI CROS RIC RT</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>63332-423</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:28:01.471Z</lastUpdated>
  </row>
</eudamedExport>