Certifications

  • Haldor quality system complies with the ISO 13485 standard for Medical Devices.
  • 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:


FDA 510K Letter


ISO-13485-2016 Certificate


FCC Authorization