PregSure Digital Pregnancy Test' and 'PregSure Pregnancy Test' (Cancelled from the ARTG under s.41GN (1) (b) and 41GN (1) (e))
Product name
PregSure Digital Pregnancy Test' and 'PregSure Pregnancy Test'
Sponsor
ARTG
236402
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN (1) (b) and 41GN (1) (e)
Grounds for regulatory action
As the sponsor did not provide evidence that the devices are safe or perform as intended, nor did the sponsor provide information to substantiate compliance with the Essential Principles; the sponsor failed to comply with conditions to which inclusion of the kind of device in the ARTG was subject under 41FN(3)(a).