ARTG 473716Surgical power tool system handpiece, rotary, non-rechargeable battery-powered, single-use
ARTG ID: 473716 · Lyka Smith Pty Ltd · Jeil Medical Corporation · Class IIa · Started December 18, 2024
Good Name: Lyka Smith Pty Ltd - Surgical power tool system handpiece, rotary, non-rechargeable battery-powered, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 473716
- Start Date
- December 18, 2024
- Effective Date
- December 18, 2024
- 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
The SMARTO is intended for use in driving screws, and drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomnies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.
Access comprehensive regulatory information for Surgical power tool system handpiece, rotary, non-rechargeable battery-powered, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 473716 and sponsored by Lyka Smith Pty Ltd, manufactured by Jeil Medical Corporation in South Korea. The device registration started on December 18, 2024.
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.