Pure Global

CPAP/BiPAP nasal mask, reusable

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
Class IIa
CPAP/BiPAP nasal mask, reusable
Australia TGA ARTG Registered Device
Good Name: Draeger Australia Pty Ltd - CPAP/BiPAP nasal mask, reusable
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

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
Manufacturer
Country
United States of America
Address
5 Merrill Industrial Drive, Hampton, NH, 03842