Cranial orthosis - ARTG 437520
Access comprehensive regulatory information for Cranial orthosis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 437520 and sponsored by Massons Healthcare, manufactured by Invent Medical Group Ltd in Czech Republic. The device registration started on January 25, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
A patient-matched helmet-like device, intended to be worn on the head of an infant with an abnormal head shape (e.g. due to plagiocephaly, brachycephaly) to improve cranial symmetry/shape during growth over a period of months. It is typically worn during daily activities and sleep. Made of durable materials this is a single-patient device that can be reapplied during the treatment period before being discarded