Dirigeants et représentants réglementaires de Fibrothelium GmbH
LEEMHUIS Hans
the following tasks according to Regulation (EU) 2017/745, Article 15(3): (a) checking the conformity of the devices appropriately, in accordance with the quality management system under wich the devices are manufactured, before a device is released
and
substitute for Lisa Lauts.
Masqué
LAUTS Lisa
the following tasks according to Regulation (EU) 2017/745, Article 15(3):
(b) the technical documentation and the EU declaration of conformity
(c) the post-market surveillance obligations in accordance with Article 10(10)
(d) the reporting obligation referred to in Articles 87 to 91
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV
and
substitute for Hans Leemhuis.