We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Ophthalmic ultraviolet phototherapy solution (Cancelled from the ARTG under s.41GN1(b) and (f))
Product name
Ophthalmic ultraviolet phototherapy solution
Sponsor
ARTG details
- 262531
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN1(b) and (f)
Grounds for regulatory action
As the sponsor did not provide sufficient information to substantiate that the appropriate conformity assessment procedures have been applied to the kind of device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the inclusion of the device in the ARTG were correct, in a material particular.