United Kingdom MHRA device registration 107226

Audiometric/hearing device software

United Kingdom·General Medical Device·Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN·Registered Sep 24, 2024

Registration details

Device ID: 107226
MHRA Reference Number: 107226
Date Registered: Sep 24, 2024
Last Updated: May 24, 2024

Device classification

Device Type: General Medical Device
Devices: Audiometric/hearing device software
Type: Class IIa

Manufacturer

Name: Starkey Laboratories, Inc. dba Starkey Hearing Technologies under the brand names Starkey, Paradigm, Audibel, AudioSync, Audika, VISAUDIO, ProAkustik, Silvertone, NuEar, MicroTech, KIND and TELEFUNKEN
Address: 6700 Washington Ave South
Eden Prairie, Minnesota, United States
Created Date: Oct 7, 2021

Authorized Representative

Name: Starkey Laboratories ltd
Relationship Type: UK Responsible Person
Address: William F Austin House Bramhall Technology Park Pepper Road Hazel Grove
Stockport, Cheshire, United Kingdom
Postcode: SK7 5BX

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Other products from 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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Additional devices represented by Starkey Laboratories ltd in the UK

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Manufacturer: BHM-Tech Produktionsgesellschaft mbH

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Device ID: 179756

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Type: General Medical Device

Device ID: 179758

Hearing aid enhanced audio device, telecommunication/multimediaNov 26, 2024

Type: General Medical Device

Device ID: 179761

Air-conduction hearing aid, wearable caseNov 26, 2024

Type: General Medical Device

Manufacturer: BHM-Tech Produktionsgesellschaft mbH

Device ID: 84241

Air-conduction hearing aid, behind-the-earNov 26, 2024

Type: General Medical Device

Device ID: 178126

Hearing aid wireless-fitting computer-aided setNov 26, 2024

Type: General Medical Device

Device ID: 179762

Hearing aid/implant system remote controlNov 26, 2024

Type: General Medical Device

Device ID: 179760

Noninvasive device battery chargerNov 26, 2024

Type: General Medical Device

Device ID: 179763

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Type: General Medical Device

Device ID: 179759

About this record

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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