We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Aussie Medi Tech Pty Ltd - Urogenital surgical laser system beam guide, reusable (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Urogenital surgical laser system beam guide, reusable
Sponsor
ARTG
295573
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
Cancelled on the basis that the sponsor did not provide sufficient information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject, and the certifications made are incorrect, or are no longer correct, in a material particular.