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Foetal blood sampling kit, scalp - ARTG 311506

Access comprehensive regulatory information for Foetal blood sampling kit, scalp in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 311506 and 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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Class IIa
ARTG 311506
Class IIa
Foetal blood sampling kit, scalp
ARTG ID: 311506
Good Name: EMT Healthcare Pty Ltd - Foetal blood sampling kit, scalp
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Intended Purpose

Intended to be used to collect blood from the foetal scalp transcervically during labour or obstetric endoscopic procedures by piercing the foetal scalp with a short blade. This device includes instruments to pierce the scalp and take a blood sample. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
311506
Start Date
November 14, 2018
Effective Date
November 14, 2018
Manufacturer
Country
United Kingdom
Address
13 The Chestnuts, Abingdon, Oxfordshire