CAD/CAM unit, orthopaedic [41018] (Cancelled under s.41GN(1)(f))
Product name
CAD/CAM unit, orthopaedic [41018]
Sponsor
ARTG
208813
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled under s.41GN(1)(f)
Grounds for regulatory action
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.