Ebos Medical Devices Australia Pty Ltd - Urogenital surgical laser system beam guide (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Urogenital surgical laser system beam guide
ARTG
289656
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 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.