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Needle, injector, medication/vaccine

Australia TGA ARTG Registered Device · Roche Diabetes Care Australia Pty Ltd · HTL-Strefa S A · Class IIa · Started October 24, 2022

Good Name: Roche Diabetes Care Australia Pty Ltd - Needle, injector, medication/vaccine

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
October 24, 2022
Effective Date
October 24, 2022
Sponsor
Manufacturer
Country
Poland
Address
ul Adamowek 7, Ozorkow, 95-035
Intended purpose

Pen needles that are intended to be used with pen injector devices for the subcutaneous injection of drugs

About this record

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 sponsored by Roche Diabetes Care Australia Pty Ltd, manufactured by HTL-Strefa S A in Poland. The device registration started on October 24, 2022.

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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