Danas Dental Supplies Pty Ltd

Regulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect.As the device labelling did not comply with the essential principles, the certification made under s.41FD(d) was incorrect.As the sponsor was not identified in the product information, the sponsor failed to comply with a condition of inclusion imposed under s.41FO.As the sponsor failed to supply evidence that conformity assessment procedures have been applied to the device, the certifications made under s.41FD(f) and (g) were incorrect., effective 13/09/2013