Quality and Regulatory

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

MDSAP Certified

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

ISO 13485:2016 Certified

Eko maintains an ISO 13485 certified Quality Manufacturing System.

FDA Cleared

Eko CORE and Eko DUO are cleared by the FDA for sale in the United States.

CE Cleared

Eko CORE is CE Cleared for sale within the European Union. Eko DUO will be CE Cleared soon.

Health Canada approved

Eko CORE is Health Canada approved for sale in Canada. Eko DUO will be approved for sale in Canada soon.

TGA (Australia) approved

Eko CORE is TGA approved for sale in Australia. Eko DUO will be approved for sale in Australia soon.