Impeto Medical complies with State and Federal regulations regarding the manufacture and sale of EZSCAN, SUDOSCAN+ and SUDOSCAN.
Europe
EZSCAN is in conformity with the European Medical device directive 93/42. The EC certification was delivered by the SNCH on 20 october 2009. This certificate is subject to a yearly surveillance.
China
EZSCAN has been appproved by the China SFDA (State Food and Drug Administration) as a medical device.
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.
USA
SUDOSCAN is approved by the US Food and Drug Administration (FDA).
Canada
EZSCAN is licensed in Canada.
Thailand
EZSCAN is approved by the Thai Food and Drug Administration (TFDA).
Indonesia
EZSCAN is approved by the Indonesian Ministry of Health.
Lien RSS