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Haematology full blood count IVDs - ARTG 345293

Access comprehensive regulatory information for Haematology full blood count IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 345293 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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Class IIa
ARTG 345293
Class IIa
Haematology full blood count IVDs
ARTG ID: 345293
Good Name: Point Of Care Diagnostics Australia Pty Ltd - Haematology full blood count IVDs
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Intended Purpose

IVDs that are intended to be used for the qualitative and/or quantitative haematological determination of measured and/or calculated whole blood cell parameters.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
345293
Start Date
October 01, 2020
Effective Date
October 01, 2020
Manufacturer
Country
Israel
Address
6 Hayezira Street PO Box 113, Yokneam, Ilit, 2069202