Australia TGA ARTG record

Insulin syringe, fixed-needle

Australia TGA ARTG Registered Device · Mondeal P/L · Shina Corporation · Class IIa · Started July 17, 2020

Good Name: Mondeal P/L - Insulin syringe, fixed-needle

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 17, 2020
Effective Date: July 17, 2020

Sponsor

Name: Mondeal P/L

Manufacturer

Name: Shina Corporation
Country: South Korea
Address: 8-26 Bojeodong-gil Useong-myeon, Gongji-si, Chungcheongnam-do

Intended purpose

to administer an injection of insulin to a patient subcutaneously

About this record

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 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.