Pure Global

Onda - Skin Contouring system, Multifunction - Skin contouring system, multifunction - ARTG 385892

Access comprehensive regulatory information for Onda - Skin Contouring system, Multifunction - Skin contouring system, multifunction in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 385892 and sponsored by Jonathan Kew Private Assists, manufactured by Deka M E L A Srl in Italy. The device registration started on March 18, 2022.

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 IIb
ARTG 385892
Class IIb
Onda - Skin Contouring system, Multifunction - Skin contouring system, multifunction
ARTG ID: 385892
Good Name: Jonathan Kew Private Assists - Onda - Skin Contouring system, Multifunction - Skin contouring system, multifunction
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Onda system is a medical device intended for deep heating of the adipose tissue for the treatment of lipodystrophy, edematous fibrosclerotic panniculopathy and for body contouring in dermatological, plastic surgery and aesthetic medicine environments.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
385892
Start Date
March 18, 2022
Effective Date
March 18, 2022
Manufacturer
Country
Italy
Address
Via Baldanzese 17, Calenzano Firenze, FI, 50041