Quality and Regulatory

Our 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).

MDSAP Certificate

ISO 13485:2016 Certified

Eko maintains an ISO 13485 certified Quality Manufacturing System.

ISO 13485 Certificate

FDA Cleared

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

Eko CORE FDA Clearance Statement K151319Eko DUO FDA Clearance Statement K170874

CE Cleared

Eko CORE is CE Cleared for sale within the European Union.

Eko DUO will be CE Cleared soon.

CE certificate

Health Canada approved

Eko CORE is Health Canada approved for sale in Canada.

Eko DUO will be approved for sale in Canada soon.

Health Canada license

TGA (Australia) approved

Eko CORE is TGA approved for sale in Australia.

Eko DUO will be approved for sale in Australia soon.

TGA license