US FDA Good Manufacturing Practice (GMP). We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.

View our Establishment Registration on the FDA website.

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
Telephone: +31.70.345.8570

AUSTRALIA – Sponsor Representative
Emergo Australia, Sydney, Australia
Telephone: +61.2.9006.1662