The MitoCABIN 2.0 is built to both our own high standards as well as many international standards, both voluntary and mandatory. Here is a full list of the standards that our product is built to.

• UL - IEC 60601 sets safety and performance requirements for devices intended to diagnose, treat, or monitor patients under medical supervision. It applies to electrically powered medical equipment, including devices used in hospitals, clinics, or professional wellness settings.
• ETL - A safety certification for products that meet North American electrical, sanitation, and operational safety standards. It's administered by Intertek, an independent testing organization.
• CE - The CE standard is a mark that indicates a product meets European Union (EU) safety, health, and environmental regulations.
• MDSAP - The Medical Device Single Audit Program (MDSAP) is a program that allows third-party auditors to perform a single audit of a medical device manufacturer. The audit covers the manufacturer's quality management system and regulatory requirements.
• ISO 13485 - Manufactured in a facility that meets ISO international quality standards. Ensuring safety and quality in the design, manufacturing, and installation of medical devices.
• FDA Class II - Our Mito Red Commercial Premiere is manufactured in an registered FDA Class two manufacturing facility.