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Regulatory Information

Quality Management System

ISO 13485:2016 quality system certification
US FDA (21 CR Part 820) compliance
We are fully compliant with the US FDA Quality System Regulation. View our Establishment Registration on the FDA website.


Aspen Medical Products maintains ISO 13485 certification and is audited every year by:
789 N Dixboro Road
Ann Arbor, MI 48105 USA
Telephone: +1-734-827-6800

European Authorized Representative

Emergo Europe
Prinsesegracht 20
2514 AP The Hague
The Netherlands
Telephone: +31-70-345-8570

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