رگــــلاتـوری

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, EZSCAN2 and SUDOSCAN2 are cleared by the China FDA (State Food and Drug Administration) as medical devices.
> CFDA Certificate
> CFDA Certificate (Extension)
> CFDA Certificate (SUDOSCAN2 & EZSCAN2)

SUDOSCAN is cleared by the US Food and Drug Administration (FDA).

• FDA approval

SUDOSCAN is registered as a trademark in the US.

• SUDOSCAN TM
• The lattest letter of clearance for the 510(k) 

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

EZSCAN and SUDOSCAN are licensed in Canada.

• EZSCAN Canada licence
• SUDOSCAN Canada licence

EZSCAN is cleared by the COFEPRIS.

• Certificate SUDOSCAN (currently being renewed)

SUDOSCAN is cleared for sale by the Korean Food and Drug Administration.

• Certificate SUDOSCAN (currently being renewed)

SUDOSCAN is cleared by the Thai Food and Drug Administration (TFDA).

•  Certificate SUDOSCAN

• Certificate EZSCAN

• Certificate SUDOSCAN

• Certificate SUDOSCAN

• Certificate EZSCAN & SUDOSCAN (currently being renewed)

• Kingdom of Morocco authorisation for EZSCAN2
• Kingdom of Morocco authorisation for SUDOSCAN2