Based on the 4/2009. (III.17.) EüM decree, our medical soft lasers are medical devices belonging to Class IIa of medical devices.

Our company possesses a quality management system defined by the MSZ EN ISO 13485:2016 standard and the 4/2009. (III.17) EüM decree.

This standard defines the following processes for medical devices:

• design
• development
• manufacturing
• service
• sales.

The certification ensures that the user receives a safe, effective, quality-controlled device with adequate service support.

In the EU, only medical devices with a CE mark can be placed on the market!

EC certificate number: 144783-18-09-05

Quality management system certificate number: 144784-18-09-05

Certifying body: CE Certiso Medical and Hospital Technology Inspection and Certification Ltd. (NB 2409)