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Instrument/analyser IVDs - ARTG 345294

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 345294 and sponsored by Point Of Care Diagnostics Australia Pty Ltd, manufactured by PixCell Medical Ltd in Israel. The device registration started on October 01, 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.

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TGA ARTG Official Data
Class I
ARTG 345294
Class I
Instrument/analyser IVDs
ARTG ID: 345294
Good Name: Point Of Care Diagnostics Australia Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

Device intended by the manufacturer to be used as an in vitro diagnostic medical device (IVD) for the purposes of processing, examining and/or providing information about a clinical specimen.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
345294
Start Date
October 01, 2020
Effective Date
October 01, 2020
Manufacturer
Country
Israel
Address
6 Hayezira Street PO Box 113, Yokneam, Ilit, 2069202