Audiometric/hearing device software - UK MHRA Medical Device Registration
Audiometric/hearing device software is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 107226. The device is manufactured by Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN from United States, classified as General Medical Device. The authorized representative in the UK is Starkey Laboratories ltd.
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Device Type
General Medical Device
Devices
Audiometric/hearing device software
Type
Class IIa
Date Registered
Sep 24, 2024
Last Updated
May 24, 2024
Address
6700 Washington Ave South
Eden Prairie, Minnesota, United States
Created Date
Oct 7, 2021
Relationship Type
Address
William F Austin House Bramhall Technology Park Pepper Road Hazel Grove
Stockport, Cheshire, United Kingdom
Postcode: SK7 5BX
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Type: General Medical Device
Manufacturer: Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN
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Type: General Medical Device
Manufacturer: Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN
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Type: General Medical Device
Manufacturer: Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN
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Type: General Medical Device
Manufacturer: Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN
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Manufacturer: Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN
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Type: General Medical Device
Manufacturer: Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN
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Type: General Medical Device
Manufacturer: Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN
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Type: General Medical Device
Manufacturer: Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN