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 134852003/AC:2009

EN IEC 60601-1:1990+A1+A2+A13
EN IEC 60601-1-3:2008/AC:2010
EN IEC 60601-1-2:2007
EN IEC 60601-1-4:2000
EN IEC 60601-2-7:1998
EN IEC 60601-1-2-28:2010
EN IEC 60601-2-32:1994
EN ISO 14971:2009

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