Avantra® Q400 Regulatory Compliance

Courtagen partners with Columbia Tech to manufacture the Avantra® Q400 Workstation

Columbia Tech Certifications

Avantra® Q400 Certifications

  • J-STD-001 Certified
  • CSA 61010-01 Approved
  • ISO 13485:2003
  • IQ, OQ, PQ (available upon request)

  • IEC 60825

  • EN 61010

 "The Devices made by Courtagen and contained in this website are intended for research use only and not for diagnostic use such as reporting patient-specific results or for making medical decisions in clinical trials. These devices have not been reviewed by the FDA."