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Tube/mask breathing circuit connector, non-sterile, single-use

Access comprehensive regulatory information for Tube/mask breathing circuit connector, non-sterile, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Medline International Two Australia Pty Ltd, manufactured by Galemed Xiamen Co Ltd in China. The device registration started on September 28, 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.

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TGA ARTG Official Data
Class IIb
Class IIb
Tube/mask breathing circuit connector, non-sterile, single-use
Australia TGA ARTG Registered Device
Good Name: Medline International Two Australia Pty Ltd - Tube/mask breathing circuit connector, non-sterile, single-use
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Intended Purpose

Intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anesthesia face mask, or other non-sampling breathing circuit component. Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 28, 2023
Effective Date
September 28, 2023
Manufacturer
Country
China
Address
Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39 Section 3 Hajing East Road, Fujian Province, 361026