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Surgical drill guide, reusable - ARTG 483408

Access comprehensive regulatory information for Surgical drill guide, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 483408 and sponsored by Lyka Smith Pty Ltd, manufactured by Jeil Medical Corporation in South Korea. The device registration started on March 20, 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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Class I
ARTG 483408
Class I
Surgical drill guide, reusable
ARTG ID: 483408
Good Name: Lyka Smith Pty Ltd - Surgical drill guide, reusable
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Intended Purpose

A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch).

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
483408
Start Date
March 20, 2025
Effective Date
March 20, 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