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

JAPAN Designated MAH
Emergo Japan K.K., Tokyo, JAPAN
Telephone: +81.3.3350.9656
http://www.EmergoGroup.com

UNITED STATES US FDA Agent
Emergo Group, Inc., Austin, Texas USA
Telephone: +1.512.327.9997
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