Impeto Medical complies with State and Federal regulations regarding the manufacture and sale of EZSCAN and SUDOSCAN.
Updated: January 2019
EZSCAN and SUDOSCAN are in conformity with the European Medical device directive 93/42 (class IIa) and ISO 13485:2016. The certificates were delivered by SGS.
> CE certificate_SGS valid until 17 December 2023 and is subject to a yearly surveillance.
> ISO 13485:2016 Certificate Impeto Medical (Paris) valid until 17 december 2021 and is subject to a yearly surveillance.
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.
- Certificate EZSCAN & SUDOSCAN (currently being renewed)