Impeto Medical مطابق با مقررات دولتی و فدرال در زمینه تولید و فروش EZSCAN و SUDOSCAN است.
به روز شده: ژانویه ۲۰۱۹
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).
SUDOSCAN is registered as a trademark in the US.
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.
SUDOSCAN is cleared for sale by the Korean Food and Drug Administration.
- Certificate SUDOSCAN (currently being renewed)
- Certificate EZSCAN & SUDOSCAN (currently being renewed)