Device Dossier
Balloon, intrauterine
Device Dossier for Balloon, intrauterine (Intrauterine haemostatic balloon catheter, Class IIa, sponsor Stark Medical). ARTG record, intended purpose,…
- GMDN category: Intrauterine haemostatic balloon catheter
Intended purpose
Intended to provide tamponade for controlling haemorrhage after vaginal or caesarean delivery. By applying pressure, it helps reduce postpartum bleeding. It may include an additional balloon that can be inflated in the upper vagina to seal the uterine cavity. This is a single use device