The Rayocomp PS 10 med. is a Class IIa medical device approved according to the latest European directives and bears the certification number of the notified body on the rear side.
Here at a glance the classification of all the Rayocomp PS 10 devices:
Rayocomp PS 10 med.: Class IIa medical device
Rayocomp PS 10 VET: Non-medical device
Rayocomp PS 10 TCM: Non-medical device
Rayocomp PS 10 BB: Non-medical device
Rayocomp PS 10 Evolution: Non-medical device
Rayocomp PS 10 basic: Non-medical device
Rayocomp PS 10 Complete-Edition: Non-medical device
Rayocomp PS 10 Edition 35 Non-medical device
The Rayocomp PS 10 Edition 35 has been developed for medical applications in accordance with its intended use. Our quality management system in accordance with DIN EN ISO 13485 (Risk management for medical products) and the regular audits by our notified body ensure the consistently high quality of this portable medical bioresonance device according to Paul Schmidt from Rayonex Biomedical GmbH.
Highlights of the new Rayocomp PS 10 med.:
➤ Latest approval as a Class IIa medical product in accordance with DIN EN 60601-1:2013-12 and DIN EN 60601-1-2:2016-05
The device meets all the requirements of the new medical product standards that have been in force since 1 January 2019.
➤ Portable thanks to integrated rechargeable battery and low weight
Despite the integrated rechargeable battery, the Rayocomp PS 10 med. weighs only 1.7 kg. As a result, the device is ideal for use also e.g. in home care in the patient’s home.