Eko has been audited per the requirements of the Medical Device Single Audit Program (MDSAP).
Eko maintains an ISO 13485 certified Quality Manufacturing System.
Eko CORE, Eko DUO, and Eko Analysis Software are cleared by the FDA for sale in the United States.
Eko CORE and DUO are CE Marked for sale within the European Union.
Eko CORE and DUO are Health Canada approved for sale in Canada.
Eko CORE and DUO are TGA approved for sale in Australia.
Eko CORE is ANVISA approved for sale in Brazil.