Regulatory Compliance Information

ClaroNav is proud to report that it has achieved and maintains compliance with regulatory requirements throughout the world. Our products are designed and manufactured under our ISO 13485:2016 and FDA-compliant Quality Management System and our products are certified to all applicable standards. Please see the list below for our international registrations.

Quality Management System

ISO 13485 quality system certification (PDF format)

ISO 13485:2016 MDSAP CertificateEN ISO 13485:2016 Certificate

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.

Product Certifications and Approvals

Australia - Devices listed in ARTGCanada - Medical Device LicensesEurope - CE Marking certificatesEurope - Declarations of ConformityMexicoTaiwan - FDAThailandUnited Arab Emirates - MOH classification certificateUnited States - FDA 510(k) cleared devices

Global Regulatory Representatives

Shown below are in-country regulatory representatives for issues and incident reporting.

Australia - Sponsor Representative

Emergo Australia
Sydney, Australia
Telephone: +61.2.9006.1662

Europe - Authorized Representative

Emergo Europe
‍The Hague, Netherlands
Telephone: +31.70.345.8570

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