Addition Technology Inc. complies, among others, with 21 CFR 820, ISO standards and the Medical Device Directive (MDD) 93/42/EEC.
Addition Technology Inc. products are registered worldwide.
In the United States, we hold a Premarket Approval (PMA) since 1999, a Humanitarian Device Exemption (HDE) since 2004 and 510K clearances.
In Canada, our active Medical Device License was first issue in 2007.
In Europe, our CE Mark and ISO 13485 certificates can be downloaded below.
For specific countries and certifications, information may be provided if you contact us.