Regulatory

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

Updated: May 2017

Europe

Sudoscan Ezscan 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

China

Ezscan china

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

> CFDA Certificate (Extension)

U.S.A.

Sudoscan usa

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) 

Australia

Ezscan 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.
> Australia certificate

Canada

Ezscan sudoscan canada

EZSCAN and SUDOSCAN are licensed in Canada.
> EZSCAN Canada licence
> SUDOSCAN Canada licence

Mexico

Ezscan Mexico

EZSCAN is cleared by the COFEPRIS.
Certificate SUDOSCAN

South Korea

Flag_of_South_Korea.svg

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

Thailand

Ezscan Thailand

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

Argentina

Peru

Japan

Saudi Arabia

Serbia

Singapour

1024px-Flag_of_Singapore.svg

> Singapore authorisation for  EZSCAN
> Singapore authorisation for  SUDOSCAN

Morocco

Regulatory

> Kingdom of Morocco authorisation for EZSCAN2
> Kingdom of Morocco authorisation for SUDOSCAN2