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Amnioscope, rigid, transcervical

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Amnioscope, rigid, transcervical
Australia TGA ARTG Registered Device
Good Name: EMT Healthcare Pty Ltd - Amnioscope, rigid, transcervical
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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.

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
Manufacturer
Country
United Kingdom
Address
13 The Chestnuts, Abingdon, Oxfordshire