Device Dossier

Foetal Doppler system

Device Dossier for Foetal Doppler system (Foetal Doppler system, Class IIb, sponsor Heramed). ARTG record, intended purpose, GMDN category — compiled by…

Intended purpose

The HeraBEAT hand-held doppler device and associated/companion app is intended to detect and monitor foetal and maternal heart rate. The device is intended to be used by trained pregnant women in a home environment as part of their clinically supervised care plan. The device is to be supplied via a relevant trained healthcare professional who can access and interpret the results from the product’s dashboard.

TGA Public Summary