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
Emergo Group Website
CHINA Legal Agent & After Sales Agent
Jyton & Emergo Co. Ltd., Beijing, CHINA
Telephone: +86.10.8260.9650
Emergo Group Website
EUROPE Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
Emergo Group Website
Notified Body / Registrar / Certification Body
AccuVein maintains ISO 13485:2016 certification and is audited every year by:
BSI Group
12110 Sunset Hills Road
Suite 200
Reston, Virginia 20190
1-800-862-4977
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About BSI