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Hypodermic needle, single-use, sterile - ARTG 477045

Access comprehensive regulatory information for Hypodermic needle, single-use, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 477045 and sponsored by Pfizer Australia Pty Ltd, manufactured by King Pharmaceuticals Inc in United States of America. The device registration started on January 29, 2025.

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 477045
Class IIa
Hypodermic needle, single-use, sterile
ARTG ID: 477045
Good Name: Pfizer Australia Pty Ltd - Hypodermic needle, single-use, sterile
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Intended Purpose

A pack containing pre-filled syringe(s) with a single dose of medication (benzathine benzylpenicillin tetrahydrate), with associated needle(s) for administration of the medication. This is a single use device.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
477045
Start Date
January 29, 2025
Effective Date
January 29, 2025
Manufacturer
Country
United States of America
Address
1200 Parkdale Road, Rochester, Michigan, 48307-1744