Polyrey Medical Tech(Suzhou) Co., Ltd.

(a) ensuring that the conformity of the devices is appropriately checked; (b) ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) ensuring that the post-market surveillance obligations are complied with; (d) ensuring that the reporting obligations are fulfilled; (e) ensuring that in the case of investigational devices, the statement is issued.