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 Certificate (ClaroNav) EN ISO 13485:2016 Certificate (ClaroNav) 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

CANADA – Medical Device Licenses

Navident | Navient ENT | Navient Cranial

CHINA – NMPA

ECUADOR

EUROPE – CE Marking certificates (PDF format)

Navident | Navient

EUROPE – Declarations of Conformity (PDF format)

Navident | MicronTracker | Navient

IRAQ

MEXICO

KOREA – MFDS

SINGAPORE – Devices listed in Singapore Medical Device Register

SIR LANKA

SYRIA

TAIWAN – FDA

THAILAND

UNITED ARAB EMIRATES – MOH classification certificate

Navident | Navient

UNITED STATES – FDA 510(k) cleared devices

Navident | Navient

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

SINGAPORE – Registrant

QST Dental PTE. LTD.

150 Kampong Ampat, KA Centre #07-01, Singapore 368324

Tel. No. : 93864634 Fax No. : 62736260