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 136029. The device is manufactured by SBO Hearing A/S from Denmark, classified as General Medical Device. The authorized representative in the UK is Oticon Limited.

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Audiometric/hearing device software

MHRA Device ID: 136029•Ref: 136029

Device Type

General Medical Device

Devices

Audiometric/hearing device software

Type

Class IIa

Date Registered

Nov 26, 2024

Last Updated

Jul 10, 2024

Manufacturer Information

Name

SBO Hearing A/S

Address

SBO Hearing A/S Kongebakken 9

Smørum, Denmark

Created Date

Aug 31, 2021

Authorized Representative

Name

Oticon Limited

Relationship Type

UK Responsible Person

Address

Cadzow Industrial Estate

Hamilton, Lanarkshire, United Kingdom

Postcode: ML3 7QE

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Audiometric/hearing device software - UK MHRA Medical Device Registration

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