Certifications

  • The Haldor Advanced Technology Ltd. quality system meets all the quality system requirements for regulatory purposes for Medical Devices and holds a valid ISO 13485 certificate for its quality system.
  • Haldor's product, the ORLocate™ system, meets all the regulatory requirements for Medical Devices in the USA and Europe.
  • Main certificates Haldor holds:
          ISO–13485, 2003 – Haldor (valid through 31-Oct-2013)

          CE certificate 10 0933_V_ITC – ORLocate System

          CE certificate 10 0934_QS_NB – RFID Tagged Sponges

          FDA 510k cleared – ORLocate