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Needle, suture, general-purpose

Access comprehensive regulatory information for Needle, suture, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Mondeal P/L, manufactured by HansBiomed Corp in South Korea. The device registration started on June 24, 2019.

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 I
Class I
Needle, suture, general-purpose
Australia TGA ARTG Registered Device
Good Name: Mondeal P/L- Needle, suture, general-purpose
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Intended Purpose

This device is a stainless trocar which is used to insert a suture or thread into tissues. The device consists of a sharp needle which is easy to penetrate into tissues and a tube for inserting a suture or thread. Must be sterilized before use.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 24, 2019
Effective Date
June 24, 2019
Sponsor
Manufacturer
Country
South Korea
Address
64 Yuseong-daero 1628beon-gil Yuseong-gu, Daejeon, 34054