Australia TGA ARTG record

CPAP/BiPAP nasal mask, reusable

Australia TGA ARTG Registered Device · Draeger Australia Pty Ltd · Sleepnet Corporation · Class IIa · Started August 02, 2016

Good Name: Draeger Australia Pty Ltd - CPAP/BiPAP nasal mask, reusable

Device classification

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

Registration information

Start Date: August 02, 2016
Effective Date: August 02, 2016

Sponsor

Name: Draeger Australia Pty Ltd

Manufacturer

Name: Sleepnet Corporation
Country: United States of America
Address: 5 Merrill Industrial Drive, Hampton, NH, 03842

Intended purpose

The Mini Me Paediatric Nasal Non-Vented Mask is intended to provide an interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems containing exhalation valves. It is intended for patients >2 years old and <12 years old.

About this record

Access comprehensive regulatory information for CPAP/BiPAP nasal mask, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Draeger Australia Pty Ltd, manufactured by Sleepnet Corporation in United States of America. The device registration started on August 02, 2016.

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.