Regulatory

Impeto Medical complies with State and Federal regulations regarding the manufacture and sale of EZSCAN and SUDOSCAN.

Updated: January 2019

 

 

Europe

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

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)

Regulatory

U.S.A.

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

SUDOSCAN is registered as a trademark in the US.

australia

Australia

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.

canada

Canada

EZSCAN and SUDOSCAN are licensed in Canada.

Ezscan Mexico

Mexico

EZSCAN is cleared by the COFEPRIS.

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South Korea

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

Ezscan Thailand

Thailand

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

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Saudi Arabia

  • Certificate EZSCAN & SUDOSCAN (currently being renewed)

Regulatory

Morocco

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