Australia flagARTG 457912

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

ARTG ID: 457912 · Bowa Medical ANZ Pty Ltd · S R A Developments Ltd · Class IIb · Started July 31, 2024

Good Name: Bowa Medical ANZ Pty Ltd - LOTUS Ultrasonic Surgical System & Accessories - Electrosurgical system, ultrasonic/mechanical vibration

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
Sponsor
Manufacturer
Country
United Kingdom
Address
Bremridge House Bremridge, Ashburton, Devon, TQ13 7JX
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.

About this record

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.

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