Pure Global

LOTUS Ultrasonic Surgical System & Accessories - Electrosurgical system, ultrasonic/mechanical vibration - ARTG 457912

Access comprehensive regulatory information for LOTUS Ultrasonic Surgical System & Accessories - Electrosurgical system, ultrasonic/mechanical vibration in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 457912 and sponsored by Bowa Medical ANZ Pty Ltd, manufactured by S R A Developments Ltd in United Kingdom. The device registration started on July 31, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 457912
Class IIb
LOTUS Ultrasonic Surgical System & Accessories - Electrosurgical system, ultrasonic/mechanical vibration
ARTG ID: 457912
Good Name: Bowa Medical ANZ Pty Ltd - LOTUS Ultrasonic Surgical System & Accessories - Electrosurgical system, ultrasonic/mechanical vibration
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Ultrasonic surgical equipment for cutting and coagulation of tissue. It is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It includes an energy-producing generator, a handpiece(s) with transducer tip(s) to convert and apply the energy, connecting cables, and a foot-switch as an option to regulate the energy. The System may be used as an adjunct to or substitute for electrosurgery, lasers, and traditional scalpels in general, plastic, gynaecologic, urologic, thoracic, exposure to orthopaedic structures (such as joint space),and other open and laparoscopic procedures in adult patients.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
457912
Start Date
July 31, 2024
Effective Date
July 31, 2024
Manufacturer
Country
United Kingdom
Address
Bremridge House Bremridge, Ashburton, Devon, TQ13 7JX