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Electronic cosmetic micro-needling handpiece - ARTG 362550

Access comprehensive regulatory information for Electronic cosmetic micro-needling handpiece in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 362550 and sponsored by SB Australia Trading Pty Ltd, manufactured by Bomtech Electronics Co Ltd in South Korea. The device registration started on April 19, 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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Class IIa
ARTG 362550
Class IIa
Electronic cosmetic micro-needling handpiece
ARTG ID: 362550
Good Name: SB Australia Trading Pty Ltd - Electronic cosmetic micro-needling handpiece
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Intended Purpose

This digital hand held cosmetic micro-needling handpiece is to be used in combination with a micro-needle cartridge for use in dermatology and plastic surgery to stimulate tissue regeneration and improve the appearance of the skin. Such application would include treatment of scar tissue, stretch marks, acne scarring, hyperpigmentation, wrinkles and hair loss as part of collagen induction therapy (CIT). It is intended for clinical use in dermatological clinic and general surgical procedures.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
362550
Start Date
April 19, 2021
Effective Date
April 19, 2021
Manufacturer
Country
South Korea
Address
322 Gonghang-Daero, Gangseo-Gu