Commitment to quality
Novoxel® is committed to Quality and to consistently maintain the level of operations required to meet customer requirements.
Novoxel® is certified and operates under a Quality Management system which complies with the requirements of ISO 13485:2016 for design, manufacture, distribution, and customer support of thermo-mechanical ablation systems for use in dermatology.
Regulation
Novoxel® is regulated and certified under ISO 13485:2016 and applicable medical device regulatory frameworks, including the EU Medical Device Regulation (EU) 2017/745 Quality Management System Certificate (MDR 725869) and the UKCA Full Quality Assurance System Certificate (UKCA 746301).
Novoxel® family of products comply with additional local regulations in the countries where they are marketed.
Counterfeit devices – a warning
We are aware of the availability of counterfeit Tixel® devices via online and offline channels. These devices are suspect of not being biocompatible, and as such, are potentially unsafe, harmful and may cause irreparable tissue damage. Please beware of counterfeits, which may lead to serious health and safety issues. Buying, selling, or being in possession of counterfeit products is illegal.
Novoxel's devices comply with strict regulatory tests. Contrary to Novoxel's devices, counterfeit Tixel® devices do not undergo any regulatory inspection and the use thereof can expose a patient to danger, including severe burning and permanent scarring.
Novoxel's devices are distributed by Novoxel's licensed distributers and are not available for sale through online popular e-commerce platforms. If you encounter a counterfeit suspect (either purchased or offered) or have doubts regarding its genuineness, please contact us without delay at info@novoxel.com.
Your clients are your most valuable asset – keep them safe.
Certificates
Certificates are subject to ongoing surveillance activities. Please refer to each PDF for the current scope and validity.