Eko has been audited per the requirements of the Medical Device Single Audit Program (MDSAP).
Eko CORE, Eko DUO, and Eko Analysis Software are cleared by the FDA for sale in the United States.
Eko CORE is CE Cleared for sale within the European Union.
Eko CORE is Health Canada approved for sale in Canada.
Eko CORE is TGA approved for sale in Australia.