PT Haloni Jane Tbk

*The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; *the post-market surveillance obligations are complied with in accordance with EU Regulation *The reporting obligations referred to EU Regulation are fulfilled; NOTE: This refers to Vigilance reporting, i.e. serious incident, field safety corrective action, and incident trend reporting). * in the case of investigational devices, the statement referred to EU Regulation