Australia TGA ARTG record

Patient monitor, apnoea

Australia TGA ARTG Registered Device · Rosisi Pty Ltd ATF McAfee Family Trust · Rober Ltd · Class IIb · Started July 28, 2020

Good Name: Rosisi Pty Ltd ATF McAfee Family Trust - Patient monitor, apnoea

Device classification

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

Registration information

Start Date: July 28, 2020
Effective Date: July 28, 2020

Sponsor

Name: Rosisi Pty Ltd ATF McAfee Family Trust

Manufacturer

Name: Rober Ltd
Country: United Kingdom
Address: Wheatbridge Road, Chesterfield, Derbyshire, S40 2AB

Intended purpose

The Respiration Monitor is intended for use on infants up to the age of 18 months, to detect cessation of respiration where movement of the abdominal wall has stopped, as an indication of apnoea.

About this record

Access comprehensive regulatory information for Patient monitor, apnoea in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Rosisi Pty Ltd ATF McAfee Family Trust, manufactured by Rober Ltd in United Kingdom. The device registration started on July 28, 2020.

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.