Hendricks Instruments Service 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 sponsor was not identified in the product information, the sponsor failed to comply with a condition of inclusion imposed under s. 41FO.As the information supplied with the device did not comply with the essential principles, the certification made under s.41FD(d) was incorrect.As the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certification made under s.41FD(f) was incorrect., effective 30/09/2013