Breas Sleep Theraphy - Home CPAP unit (60711) (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Breas Sleep Theraphy - Home CPAP unit, GMDN - 60711
ARTG details
317548
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 failed to comply with conditions of inclusion for Devices in the ARTG (see paragraph 41GN(1)(b) of the Act).
Certifications made under section 41FD of the Act in relation to the application for inclusion of the Devices in the ARTG are incorrect, or are no longer correct, in a material particular (see paragraph 41GN(1)(f) of the Act).