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Endoscopic electrosurgical electrode, bipolar, single-use

Access comprehensive regulatory information for Endoscopic electrosurgical electrode, bipolar, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Soma Lasers Australia, manufactured by Viol Co Ltd in South Korea. The device registration started on October 28, 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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TGA ARTG Official Data
Class IIb
Class IIb
Endoscopic electrosurgical electrode, bipolar, single-use
Australia TGA ARTG Registered Device
Good Name: Soma Lasers Australia - Endoscopic electrosurgical electrode, bipolar, single-use
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Intended Purpose

Sterile disposable applicator intended to be used with the skin surface treatment system for coagulating skin tissue, for the treatment of budding acne and minimizing acne scars, on the face and on the whole body

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 28, 2021
Effective Date
October 28, 2021
Manufacturer
Country
South Korea
Address
C-808 809 Bundang Technopark C 744 Pangyo-Ro Bundang-Gu Seongnam-Si, Gyeonggi-Do, 13510