Compliance

Compliance Declaration    (PDF)

Quality Management System

        ISO 13485 Quality System Certification    (PDF)

        US FDA good Manufacturing Practice (GMP)

                We are fully compliant with 21 CFR Part 820, US FDA Quality System
                Regulations

        JAPAN – Accreditation Certificate    (PDF)

Product Certification and Approvals

        AUSTRALIAN – ARTG Certificate    (PDF)

        CANADA – Medical Devices Licenses

                NC-stat    (PDF)        
                ADVANCE    (PDF)

        EUROPE – CE Marking Certificate    (PDF)

        UNITED STATES – FDA 510(k) cleared devices

                NC-stat K060584    (PDF)
                ADVANCE K070109    (PDF)
                UNIVERSAL Multi Electrodes K083818    (PDF) 
                Bioamplifier K083322    (PDF) 
                ASCEND Stimulator K091155    (PDF)

Notified Body

        TÜV Product Service GmbH

        Ridlerstrasse 65

        80339 München

        Germany

EU Authorized Representative

        Emergo Europe

        Molenstraat 15, 2513 BH

        The Hague, The Netherlands