Pure Global

Self-care monitoring web-based application software

Access comprehensive regulatory information for Self-care monitoring web-based application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Freyr Australia Pty Ltd, manufactured by Huma Therapeutics Limited in United Kingdom. The device registration started on August 02, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
Class IIb
Self-care monitoring web-based application software
Australia TGA ARTG Registered Device
Good Name: Freyr Australia Pty Ltd - Self-care monitoring web-based application software
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Intended Purpose

The Huma platform is a modular Software as a Medical Device (SaMD) which may utilise compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patientโ€™s home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalised for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualisation, goal setting and communication channels between clinicians and patients. The data displayed on the mobile app, web portal or web app can be labelled, flagged and triaged for the purposes of monitoring disease or deterioration, improvement and to support clinical decision making and to encourage self management of disease by the patients. The platform may also provide data analytics, risk scores and static algorithms that may assist in the assessment of risk prediction, diagnosis, disease monitoring and prognostication. The Huma platform can be used for adult and paediatric populations with functionality to accommodate data entry by caregivers and guardians.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 02, 2023
Effective Date
August 02, 2023
Manufacturer
Country
United Kingdom
Address
13th Floor Millbank Tower, 21-24 Millbank, London, SW1P 4QP