Regulatory

Quality Management System

ISO 13485 QUALITY SYSTEM CERTIFICATION
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US FDA GOOD MANUFACTURING PRACTICE (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
About FDA GMP

Product Certifications and Approvals

CANADA- Medical Device License
Download Medical Device License

AUSTRALIA – ARTG Certificate
Download ARTG Certificate

EUROPE – CE Marking certificate
Download CE Marking certificate

Global Regulatory Representatives

Shown below are our 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

CHINA Legal Agent & After Sales Agent
Jyton & Emergo Co. Ltd., Beijing, CHINA
Telephone: +86.10.8260.9650
http://www.EmergoGroup.com

EUROPE Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com

Notified Body / Registrar / Certification Body

AccuVein LLC maintains ISO 13485:2003 certification and is audited every year by:

BSI Group
12110 Sunset Hills Road
Suite 200
Reston, Virginia 20190
1-800-862-4977
View Certificate
About BSI

Product Patents

Twelve Patents Pending