US FDA Good Manufacturing Practice (GMP). We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
UNITED STATES – FDA 510(k) cleared/PMA approved device (link)
EUROPE – Declaration of Conformity (PDF format)
AUSTRALIA – Device listed in ARTG (PDF format)
EUROPE – Authorized Representative
Emergo Europe, The Hague, Netherlands
AUSTRALIA – Sponsor Representative
Emergo Australia, Sydney, Australia