Regulatory
Impeto Medical complies with State and Federal regulations regarding the manufacture and sale of EZSCAN and SUDOSCAN.
Updated: January 2019
EUROPE
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.
CHINA
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)
U.S.A.
SUDOSCAN is cleared by the US Food and Drug Administration (FDA).
SUDOSCAN is registered as a trademark in the US.
MEXICO
EZSCAN is cleared by the COFEPRIS.
- Certificate SUDOSCAN (currently being renewed)
SOUTH KOREA
SUDOSCAN is cleared for sale by the Korean Food and Drug Administration.
- Certificate SUDOSCAN (currently being renewed)
THAILAND
SUDOSCAN is cleared by the Thai Food and Drug Administration (TFDA).
ARGENTINA
PERU
JAPAN
SAUDI ARABIA
- Certificate EZSCAN & SUDOSCAN (currently being renewed)
MOROCCO
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