Compliance

Please reference the following materials for information regarding statements and certifications related to the product and/or company.

MDSAP Certification

EnsoData products are manufactured using a Quality Management System that is certified by Intertek under the Medical Device Single Audit Program (MDSAP) as being in conformity with ISO 13485, United States, and Health Canada regulations:

Clearances

EnsoSleep is cleared for use in the USA and Colombia.

Menu