Device Dossier

Foetal Doppler system

Device Dossier for Foetal Doppler system (Foetal Doppler system, Class IIa, sponsor Team Medical Supplies). ARTG record, intended purpose, GMDN category…

Intended purpose

A Doppler is a portable hand-held device. Its assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability. This device is intended for use by qualified healthcare professionals within hospital or clinical environments. It is not intended for over-the-counter sale or use in home settings by consumers, without the supervision of a qualified healthcare professional.

TGA Public Summary