Pure Global

Transducer assembly, ultrasound, therapeutic, hyperthermia, extracorporeal - ARTG 421571

Access comprehensive regulatory information for Transducer assembly, ultrasound, therapeutic, hyperthermia, extracorporeal in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 421571 and sponsored by Ebos Medical Devices Australia Pty Ltd, manufactured by Classys Inc in South Korea. The device registration started on September 11, 2023.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 421571
Class IIa
Transducer assembly, ultrasound, therapeutic, hyperthermia, extracorporeal
ARTG ID: 421571
Good Name: Ebos Medical Devices Australia Pty Ltd - Transducer assembly, ultrasound, therapeutic, hyperthermia, extracorporeal
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Ultraformer transducer cartridges are to be used with the Focused ultrasound therapeutic equipment systems to deliver high intensity focused ultrasound (HIFU) to provide non-surgical skin lifting and tightening.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
421571
Start Date
September 11, 2023
Effective Date
September 11, 2023
Manufacturer
Country
South Korea
Address
CLASSYS 208 Teheran-ro Gangnam-gu, Seoul