Global Regulatory Clearance Information
Medical devices must be appropriately designed, manufactured, tested and validated against a number of international Standards and Directives for risk management, safety and performance. We strive to provide the highest level of Quality Assurance to our customers with our products and services. This ultimately leads to a safer device and reliable, dependable performance whether in clinical or research applications.
The Medical Devices Directive 93/42/EEC:
CamNtech has CE marked devices in Class 1 and devices classified as ‘non-medical’ based upon their intended use. The table below provides details of the classification within the EU for each device family.
Please contact CamNtech for advice on the suitable aplication of devices.
FDA Clearance (USA):
CamNtech has submitted the required documentation to the United States Food and Drug Administration (FDA) under the 510(k) program. Each device has been found to be substantially equivalent to predicate devices in terms of Indications For Use, design and safety. Each device has been cleared by the FDA to be marketed as a medical device in the USA with the following 510(k) numbers:
Customers in the USA should contact our Texas office
CamNtech has appointed Emergo Group as their Australian sponsor for the MotionWatch and PRO-Diary Motion; any adverse events affecting MotionWatch or PRO-Diary in Australia should be reported directly to Emergo as soon as possible at the following address:
Tower II, Darling Park
201 Sussex Street
Sydney, NSW 2000
The MotionWatch and PRO-Diary are listed on the ARTG as Class 1 (non-sterile, non-measuring) with reference 219452. Please click here for the ARTG summary.