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Mask, tracheostomy, air/oxygen - ARTG 422830

Access comprehensive regulatory information for Mask, tracheostomy, air/oxygen in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 422830 and sponsored by Swirl Technologies Pty Ltd T/A Parker Healthcare, manufactured by Hsiner Co Ltd in Taiwan. The device registration started on September 27, 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
ARTG 422830
Class IIb
Mask, tracheostomy, air/oxygen
ARTG ID: 422830
Good Name: Swirl Technologies Pty Ltd T/A Parker Healthcare - Mask, tracheostomy, air/oxygen
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Intended Purpose

Intended to use as an interface for administration of oxygen with nominated flow rate and oxygen concentration prescripted by the physician

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
422830
Start Date
September 27, 2023
Effective Date
September 27, 2023
Manufacturer
Country
Taiwan
Address
No 312 Jhongshan Rd Shengang District, Taichung City, Taiwan