Regulatory

Our products are designed with quality as a top priority. They are evaluated to the highest regulatory standards.

MDSAP

MDSAP Certified

Eko has been audited per the requirements of the Medical Device Single Audit Program (MDSAP).

ISO 134585

ISO 13485:2016 Certified

Eko maintains an ISO 13485 certified Quality Manufacturing System.

FDA 510k

FDA Cleared

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

CE Marked

CE Marked

Eko CORE and DUO are CE Marked for sale within the European Union.

Health Canada

Health Canada Approved

Eko CORE and DUO are Health Canada approved for sale in Canada.

TGA


TGA (Australia) Approved

Eko CORE and DUO are TGA approved for sale in Australia.

ANVISA


Brazilian Health Regulatory Agency (ANVISA) Approved

Eko CORE is ANVISA approved for sale in Brazil.

Manufacturer Address:
Eko Devices, Inc.
1212 Broadway, Suite 100
Oakland, CA 94612