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General-purpose syringe/needle

Access comprehensive regulatory information for General-purpose syringe/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 September 07, 2021.

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
Class IIa
General-purpose syringe/needle
Australia TGA ARTG Registered Device
Good Name: Mondeal P/L - General-purpose syringe/needle
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Intended Purpose

Sterile single-use Low Dead Space(LDS) syringe with fixed needle intended for injection of fluids for medical purpose.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 07, 2021
Effective Date
September 07, 2021
Sponsor
Manufacturer
Country
South Korea
Address
8-26 Bojeodong-gil Useong-myeon, Gongji-si, Chungcheongnam-do