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Surgical implant template, reusable - ARTG 483885

Access comprehensive regulatory information for Surgical implant template, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 483885 and sponsored by Lyka Smith Pty Ltd, manufactured by Jeil Medical Corporation in South Korea. The device registration started on March 25, 2025.

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
ARTG 483885
Class I
Surgical implant template, reusable
ARTG ID: 483885
Good Name: Lyka Smith Pty Ltd - Surgical implant template, reusable
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Intended Purpose

The device is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns and sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
483885
Start Date
March 25, 2025
Effective Date
March 25, 2025
Manufacturer
Country
South Korea
Address
HO & Factory1 702 703 704 705 706 707 804 805 807 812 815 ho 55 Digital ro, Guro gu, Seoul, 08378