Officers and regulatory representatives of hooijmeijer commerce
HOOIJMEIJER koen raad julian
I, Koen Hooijmeijer, Director of Zenvix, hereby declare that I assume the role of Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of Regulation (EU) 2017/745. I am responsible for ensuring device conformity, maintaining technical documentation and the EU Declaration of Conformity, fulfilling post-market surveillance obligations, and meeting vigilance reporting requirements.