Regulatory Compliance

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