Device Dossier

Prefilled self-injector, single-dose

Device Dossier for Prefilled self-injector, single-dose (Prefilled self-injector, single-dose, Class IIa, sponsor Gedeon Richter). ARTG record, intended…

Intended purpose

A procedure pack used to administer medication by injection. It contains a Afolia pre-filled pen of various strengths and corresponding number of administration needles. This is a single use device.

TGA Public Summary