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 13485:2003 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)
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 ARTG
CANADA – Medical Device Licenses
EUROPE – CE Marking certificates (PDF format)
EUROPE – Declarations of Conformity (PDF format)
UNITED STATES – FDA 510(k) cleared devices
SINGAPORE – Devices listed in Singapore Medical Device Register
GLOBAL REGULATORY REPRESENTATIVES
Shown below are in-country regulatory representatives for issues and incident reporting.
AUSTRALIA – Sponsor Representative
Emergo Australia, Sydney, Australia
EUROPE – Authorized Representative
Emergo Europe, The Hague, Netherlands
SINGAPORE – Registrant
QST Dental PTE. LTD.
150 Kampong Ampat, KA Centre #07-01, Singapore 368324
Tel. No. : 93864634 Fax No. : 62736260