Regulatory

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

Updated: May 2017

Sudoscan Ezscan europe

Europe

EZSCAN and SUDOSCAN are in conformity with the European Medical device directive 93/42 (class IIa). The EC certification was delivered by the SGS. This certificate is valid until 17 December 2017 and is subject to a yearly surveillance.
> CE certificate_SGS

Ezscan china

China

EZSCAN are cleared by the China FDA (State Food and Drug Administration) as a medical device.
> CFDA Certificate

> CFDA Certificate (Extension)

> CFDA Certificate (SUDOSCAN2 & EZSCAN2)

Sudoscan usa

U.S.A.

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

SUDOSCAN is registered as a trademark in the US.

Ezscan 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.

Ezscan sudoscan 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)

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Singapour

  • Singapore authorisation for  EZSCAN
  • Singapore authorisation for  SUDOSCAN

Regulatory

Morocco

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