Our medical soft lasers are classified as Class IIa medical devices in accordance with Hungarian Regulation 4/2009. (III.17.) of the Ministry of Health (EüM).
Our company operates a quality management system compliant with the MSZ EN ISO 13485:2016 standard and the quality requirements set forth in the Hungarian Regulation 4/2009. (III.17.) EüM.
This standard defines the quality requirements for the following processes related to medical devices:
The certification ensures that the user receives a safe, effective device of controlled quality, supported by professional servicing.
Only CE-marked medical devices may be placed on the market in the European Union.
EC Certificate Number: 144783-18-09-05
Quality Management System Certificate Number: 145223-24-07-08
Notified Body: CE Certiso CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. (NB 2409)
