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Self-injection aid - ARTG 286307

Access comprehensive regulatory information for Self-injection aid in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 286307 and sponsored by Pfizer Australia Pty Ltd, manufactured by Pfizer Manufacturing Belgium in Belgium. The device registration started on March 02, 2017.

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 I
ARTG 286307
Class I
Self-injection aid
ARTG ID: 286307
Good Name: Pfizer Australia Pty Ltd - Self-injection aid
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Intended Purpose

A device used to self-administer a subcutaneous injection by enabling the user to load a prefilled syringe assembly (syringe with medication and needle) into it and inject at the correct angle (e.g., 90 degrees to the body surface) at the pre-set depth of penetration of the needle. It is a small container in which the syringe assembly is placed and secured; the user grips the container, places it on the body surface at the injection site, and presses the plunger of the syringe to inject the medication. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
286307
Start Date
March 02, 2017
Effective Date
March 02, 2017
Manufacturer
Country
Belgium
Address
Rijksweg 12, Puurs-Sint-Amands, 2870