About Healthily AI Medical Assessment
Device name
Healthily Dot™ Symptom Checker*
*marketed as ‘Healthily Dot AI Medical Assessment’, ‘Dot AI Medical Assessment’ or’ AI Medical Assessment’
Device classification
Device conformity markings
The CE mark indicates that the medical device conforms to the Medical Device Regulation (EU) 2017/745 (MDR) and is therefore approved for placement on the EU market.
Healthily has also registered the medical device with the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the transitional provisions. MHRA reference number is 24787. This registration allows Healthily to place the CE-marked device also on the UK market lawfully.
Unique device identification number
UDI-DI: 5065019644008
Software version
v1.0.0.
Date of manufacture
23.9.2025
Manufacturer
Healthily Ltd
36 Egerton Road,
Bournemouth, BH89AY
England, United Kingdom
Country of manufacturer
EU Authorised Representative
Ethos Digital Health Ltd.
Baldonnell Business Park,
Baldonnell, Dublin, Dublin 22,
Ireland
Device Intended Use
The AI Medical Assessment is an AI-based health assessment software application intended to provide health insights and guidance.
The fundamental aim of the AI Medical Assessment is (1) to provide an overview of possible conditions and (2) to support the user to decide if there is a need to see a healthcare professional by providing possible types and levels of care.
After an assessment, the user may download their outcome.
Please read How to use Healthily Dot AI Medical assessment safely for more information.
Warnings
Please read before starting to use the AI Medical Assessment
The AI Medical Assessment is designed and intended to support the user (lay persons) to decide if there is a need to see a healthcare professional and does not provide diagnoses, medical advice or treatment recommendations.
The AI Medical Assessment cannot be used for information about babies, children under the age of 16, pregnant women, people who are immunosuppressed or on immunosuppressive treatment and people with complex or long-term conditions.
User Information website
13. Certificates
EU Quality Management System and ISO 13485 Certificates
Healthily has achieved a certification for Dot Symptom Checker (marketed as AI Medical Assessment), a class IIa medical device, following a conformity assessment by the notified body HTCert, which confirmed that Healthily has established and implemented a Quality Management System (QMS) in accordance with EU Regulation 2017/745 on medical devices.
HTCert has also issued a separate certificate confirming that the Healthily QMS complies with ISO 13485:2016 standard for quality management systems in the design and manufacture of medical devices.