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Needle, injector, medication/vaccine - ARTG 465387

Access comprehensive regulatory information for Needle, injector, medication/vaccine in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 465387 and sponsored by Point Of Care Diagnostics Australia Pty Ltd, manufactured by HTL-Strefa S A in Poland. The device registration started on October 23, 2024.

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
ARTG 465387
Class IIa
Needle, injector, medication/vaccine
ARTG ID: 465387
Good Name: Point Of Care Diagnostics Australia Pty Ltd - Needle, injector, medication/vaccine
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Intended Purpose

Pen needles are intended for use with insulin delivery pens for treatment of Diabetes

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
465387
Start Date
October 23, 2024
Effective Date
October 23, 2024
Manufacturer
Country
Poland
Address
ul Adamowek 7, Ozorkow, 95-035