Device Dossier

Assisted reproduction microtool

Device Dossier for Assisted reproduction microtool (Assisted reproduction microtool, Class IIa, sponsor Origio). ARTG record, intended purpose, GMDN…

Intended purpose

Intended for denudation of oocytes or handling of Cumulus-Oocyte-Complexes (COCs), oocytes, embryos, or biopsied cells during Assisted Reproductive Technology (ART) laboratory procedures. Applied in ART treatments and intended for denudation, i.e. to remove the cumulus from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling oocytes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm).

TGA Public Summary