G-5 Florida LLC dba Anjon Medical Technologies, dba Anjon Holdings, dba Anjon, dba Generix Medical.

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued