Australia TGA ARTG recordCPAP/BiPAP face mask, single-use
Australia TGA ARTG Registered Device · Intersurgical Australia Pty Ltd · Besmed Health Business Corp · Class IIa · Started June 25, 2021
Good Name: Intersurgical Australia Pty Ltd - CPAP/BiPAP face mask, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- June 25, 2021
- Effective Date
- June 25, 2021
- Country
- Taiwan
- Address
- No 5 Lane 116 Wu-Kong 2nd Road Wu-Ku District, New Taipei City, Taiwan, 24888
CPAP Face Masks are designed to provide the interface for CPAP or BiLEVEL to patient. This Masks is to be used as an accessory to ventilators equipped with proper alarms and safety systems for ventilator failure which is intended to monitor CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea.
Access comprehensive regulatory information for CPAP/BiPAP face mask, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Intersurgical Australia Pty Ltd, manufactured by Besmed Health Business Corp in Taiwan. The device registration started on June 25, 2021.
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.