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Ventilator, adult

Access comprehensive regulatory information for Ventilator, adult in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Bellavista Australia & New Zealand, manufactured by imtmedical ag in Switzerland. The device registration started on October 14, 2015.

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.

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Class IIb
Class IIb
Ventilator, adult
Australia TGA ARTG Registered Device
Good Name: Bellavista Australia & New Zealand - Ventilator, adult
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Intended Purpose

The bellavista 1000/1000e ventilators are intended to provide positive pressure ventilator support to adult patients starting at a tidal volume greater than or equal to 2 mL. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intra-facility transport, provided compressed oxygen is supplied in case supplemental oxygen is required.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 14, 2015
Effective Date
October 14, 2015
Manufacturer
Country
Switzerland
Address
Gewerbestrasse 8, Buchs, SG, 9470