ClaroNav Kolahi Inc. 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 Certificate  (ClaroNav Kolahi Inc.)

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  │ Navient

CANADA – Medical Device Licenses | Navient │ Navient ENT 

CHINA – NMPA │ Navient

COLOMBIA │ Navient

ECUADOR │ Navient

EGYPT │ Navient

EUROPE – CE Marking certificates (PDF format) │ Navient

EUROPE – Declarations of Conformity (PDF format) │ Navient

HONDURAS │ Navient

IRAQ │ Navient

MACEDONIA │ Navient

MEXICO │ Navient

MOROCCO │ Navient

UAE │ Navient

PERU │ Navient

PHILIPPINES | Navient │ Navient ENT 

TAIWAN – FDA | Navient │ Navient ENT

UNITED STATES – FDA 510(k) cleared devices  │ Navient

GLOBAL REGULATORY REPRESENTATIVES

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

AUSTRALIA – Sponsor Representative
Evolution Surgical Pty Ltd
Telephone: +02.9428.1084

EUROPE – Authorized Representative
Emergo Europe

Westervoortsedijk 60, 6827 AT Arnhem, The Netherlands
Telephone: +31.70.345.8570