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 FDA Clearance Statement K200776
Eko DUO FDA Clearance Statement K170874
Eko CORE/DUO Analysis Software FDA Clearance Statement K192004
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.
Eko Devices is dedicated to maintaining public trust in the integrity of our research-related activities. The management of financial conflicts of interest (FCOI) is crucial for safeguarding research objectivity and for compliance with federal regulations.
Eko Devices seeks to ensure the integrity of its research and to comply with the Public Health Service (PHS) requirements for institutions that seek research funding. The PHS has implemented regulations (42 CFR 50, “FCOI Regulations”) to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants will be free from bias resulting from investigator FCOIs.
This policy includes any research performed at Eko that is funded from NIH monies (PHS grants).
This policy includes any investigators that are participating in NIH-funded research at Eko or any subcontracting organization. The policy provides mandatory training, policy documentation and essential details on processes that investigators must follow to comply with FOCI Regulations.
Manufacturer Address:
Eko Devices, Inc.
1212 Broadway, Suite 100
Oakland, CA 94612
