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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 Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by imtmedical ag in Switzerland. The device registration started on March 24, 2020.

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: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Ventilator, adult
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Intended Purpose

The bellavista ventilator was developed for ventilating adult and paediatric patients and, optionally, neonatal patients as of a tidal volume of โ‰ฅ2 mL1. The device is intended for use in clinics and institutional facilities where medically trained professionals are available for attending to the patient. The device can be used at the bedside, as well as for transferral within a facility, when a patient is in need of oxygen. bellavista is only intended for use by trained personnel under the supervision of a licensed doctor.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 24, 2020
Effective Date
March 24, 2020
Manufacturer
Country
Switzerland
Address
Gewerbestrasse 8, Buchs, SG, 9470