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Aussie Medi Tech Pty Ltd - Collagen-remodelling radio-frequency hyperthermia system (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Collagen-remodelling radio-frequency hyperthermia system
Sponsor
ARTG details
293061
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.