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Insulin syringe, fixed-needle - ARTG 339701

Access comprehensive regulatory information for Insulin syringe, fixed-needle in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 339701 and sponsored by Mondeal P/L, manufactured by Shina Corporation in South Korea. The device registration started on July 17, 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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TGA ARTG Official Data
Class IIa
ARTG 339701
Class IIa
Insulin syringe, fixed-needle
ARTG ID: 339701
Good Name: Mondeal P/L - Insulin syringe, fixed-needle
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Intended Purpose

to administer an injection of insulin to a patient subcutaneously

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
339701
Start Date
July 17, 2020
Effective Date
July 17, 2020
Sponsor
Manufacturer
Country
South Korea
Address
8-26 Bojeodong-gil Useong-myeon, Gongji-si, Chungcheongnam-do