Regulatory compliance information

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
View our Establishment Registration on the FDA website

Medical Device Manufacturing License
California State Medical Device Manufacturing License
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Product Certifications and Approvals
Europe - Declarations of Conformity
Direct Product: Download PDF
Ventana Product: Download PDF

Global Regulatory Representatives
Shown below are our in-country representatives for regulatory affairs issues and incident reporting. For a list of our distributors worldwide, please click here.

EUROPE -Authorized Representative
Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570
Website link