Babylon Healthcheck Regulatory

Last updated 1 Oct 2021

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App Name: Healthcheck

Version Number: 4


1 Oct 2021


Babylon Partners Ltd
1 Knightsbridge Green
London, SW1X 7QA, UK
support@babylonhealth.com

+ 44 (0) 20 3637 1273


Babylon Health Ireland Ltd
North Point Business Park
New Mallow Road, Cork, Ireland
babylon.ireland@babylonhealth.com


Intended Use:

Babylon’s mobile application ‘Healthcheck’ is intended to be used as a health self-management tool.

Healthcheck collects information about the user by asking a series of questions. Using this information, Healthcheck provides the user with general health assessment insights and general wellness advice.

Healthcheck is intended to be used as a health self-management tool, to assess the users’ overall general health, in relation to lifestyle, mental health, current organ health and future disease risks within 5 years.

It is intended to be used for general wellbeing purposes or to encourage or maintain a healthy lifestyle.

Healthcheck is intended to be used in a non-clinical environment.


Warnings and Precautions:

  • Do not use Healthcheck for medical purposes such as the detection, diagnosis, prevention, monitoring, management, treatment or alleviation of any medical condition, disease or injury.
  • Do not treat any health-related information provided by this device or software as medical advice.
  • Healthcheck should not be used:
    • by anyone below the age of 18
    • by anyone whose gender identity does not match their sex assigned at birth
    • by anyone with emotional or cognitive difficulties
    • by anyone with serious or life-threatening emergencies,
    • by anyone with trauma
    • by anyone with rare conditions
    • by anyone who is pregnant
    • on behalf of others

View Healthcheck product information here.

Healthcheck has been developed in compliance with the Medical Device Regulations (EU) 2017/745.

Healthcheck is registered with the MHRA (registration number 7139) and CE marked as Class I medical device in the United Kingdom.