Certifications

  • Haldor Advanced Technology's quality system meets the requirements of the ISO 13485 standard for Medical Devices.
  • The ORLocate® System was CE certified in 2010
  • Haldor is a GS1 Industry Partner since 2013
  • The ORLocate® Product received FCC clearance in 2010
  • The ORLocate® Product has FDA 510K clearance since 2010
  • The ORLocate Product was approved by the Australian Department of Health (TGA) in 2013

Below are some of the certificates:

510K
CE100933

FDA 510K Letter

Ce Certificate 10 0933

CE100934
ISO13485

Ce Certificate 10 0934

ISO-13485 Certificate

FCC Authorization