- CE Marked, per Medical Device Directive (MDD) 93/42/EEC
- ISO 13485 Certification: Issued 30 August 2017
- TGA Registered: Issued 19 April 2017
- CMDCAS Health Canada: Issued 21 September 2012
- FDA Cleared: Issued 5 April 2007
- Guidance and Manufacturer’s Declaration
Electromagnetic Emissions and Immunity
