Certifications and Declarations

Registered FDA medical device company
Our products are designed and ETL certified to UL-60601 and are CE

Marked to
IEC 60101-1

Certified to ISO 13485:2016

EN IEC 60601-1:1990+A1+A2+A13
EN IEC 60601-1-3:2008/AC:2010
EN IEC 60601-1-2:2015
EN IEC 60601-1-4:2000
EN IEC 60601-1-6:2010
EN IEC 60601-2-2-54:2009
EN ISO 14971:2012
EN ISO 15223-1:2016
EN 62366:2008