Fresenius Medical Care (Jiangsu) Co., Ltd.

1.the conformity of the devices is appropriately checked before being released, in accordance with the QM system; 2.the TD and the EU declarations of conformity are draw up and kept up-to date; 3.the post-market surveillance obligations are complied with in accordance with Article 10(10); 4. the reporting obligations referred to in Articles 87 to 91 are fulfilled. 5. in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.