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Regulatory Compliance

​​​​​​Christie Medical Holdings is committed to the quality of its products. If you need support for technical or other issues please contact Christie Technical Support. In the unlikely event that a clinically important safety concern occurs with the product contact Christie Technical Support immediately.

VeinViewer® by Christie Medical Holdings meets quality and regulatory standards in markets around the globe. Click below to view up-to-date certifications and licenses. For more information on regulatory compliance at Christie call 877 SEE VEIN.

Quality Management System

ISO 13485 Quality System Certification

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.

Notified Body
Christie Medical Holdings, Inc. maintains ISO 13485:2003​ certification and is audited every year by:

TÜV SÜD Product Service GmbH
Ridlerstraße 65
80339 München, Germany


Product Certifications and Approvals

Canada-Medical Device License

Europe-CE Marking certificate


Global Regulatory Representatives

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

AUSTRALIA - Sponsor Representative
Emergo Australia, Sydney, Australia
Telephone: +61.2.9006.1662
http://www.emergogroup.com/services/australia/australia-tga-sponsor

BRAZIL - ANVISA Registration Holder
Emergo Brazil, Brasilia, Brazil
Telephone: +55 61 3386 3166
http://www.emergogroup.com/services/brazil/brazilian-registration-holder

EUROPE - Authorized Representative
Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570
http://www.emergogroup.com/services/europe/european-authorized-representative

MEXICO - Registration Holder
EMERGO MEXICO, Mexico City, MEXICO
Telephone: +52.55.55.33.08.32
http://www.emergogroup.com/services/mexico/mexico-registration-holder