Australia TGA ARTG record

Oxygen cylinder regulator

Australia TGA ARTG Registered Device · Cigweld Pty Ltd · GCE sro · Class IIb · Started October 18, 2023

Good Name: Cigweld Pty Ltd - Oxygen cylinder regulator

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 18, 2023
Effective Date: October 18, 2023

Sponsor

Name: Cigweld Pty Ltd

Manufacturer

Name: GCE sro
Country: Czech Republic
Address: Zizkova 381, Chotebor, 583 01

Intended purpose

A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.

About this record

Access comprehensive regulatory information for Oxygen cylinder regulator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Cigweld Pty Ltd, manufactured by GCE sro in Czech Republic. The device registration started on October 18, 2023.

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.