Impeto Medical complies with State and Federal regulations regarding the manufacture and sale of EZSCAN and SUDOSCAN.
Updated: May 2017
EZSCAN and SUDOSCAN are in conformity with the European Medical device directive 93/42 (class IIa). The EC certification was delivered by the SGS. This certificate is valid until 17 December 2017 and is subject to a yearly surveillance.
> CE certificate_SGS
EZSCAN is registered in Australia as a Medical device. The ARTG certificate has been delivered on 19 August 2009 by the Australian Department of Health and Ageing Therapeutic Goods Administration.
> Australia certificate
> Certificate EZSCAN & SUDOSCAN (currently being renewed)