Ultraviolet room disinfection system [62893] (Cancellation from the ARTG under subsection 41GN(1) of the Act.)
Product name
Ultraviolet room disinfection system [62893]
ARTG
342669
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1) of the Act.
Grounds for regulatory action
The product is an excluded good for the purposes of the Act, that is, the product is determined not to be a therapeutic good. Therefore the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion, that the product is a medical device, is incorrect.