Australia TGA ARTG record

Amnioscope, rigid, transcervical

Australia TGA ARTG Registered Device · EMT Healthcare Pty Ltd · BridgeMaster Medical Ltd · Class IIa · Started November 14, 2018

Good Name: EMT Healthcare Pty Ltd - Amnioscope, rigid, transcervical

Device classification

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

Registration information

Start Date: November 14, 2018
Effective Date: November 14, 2018

Sponsor

Name: EMT Healthcare Pty Ltd

Manufacturer

Name: BridgeMaster Medical Ltd
Country: United Kingdom
Address: 13 The Chestnuts, Abingdon, Oxfordshire

Intended purpose

A shadowless endoscope with a rigid inserted portion intended for the visual examination of the foetus while in the amnion (the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid). It is inserted via the vagina, through the maternal uterine cervix and into the amniotic cavity. This device is typically used to examine the foetus for external malformations, to obtain foetal blood or tissue samples, and for the observation of the colour and volume of amniotic fluid. This is a single-use device.

About this record

Access comprehensive regulatory information for Amnioscope, rigid, transcervical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by EMT Healthcare Pty Ltd, manufactured by BridgeMaster Medical Ltd in United Kingdom. The device registration started on November 14, 2018.

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.