Pure Global

Shaver system, handpiece, powered - ARTG 388931

Access comprehensive regulatory information for Shaver system, handpiece, powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 388931 and sponsored by Olympus Australia Pty Ltd, manufactured by Gyrus Acmi Inc in United States of America. The device registration started on May 23, 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 IIa
ARTG 388931
Class IIa
Shaver system, handpiece, powered
ARTG ID: 388931
Good Name: Olympus Australia Pty Ltd - Shaver system, handpiece, powered
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

This system is intended for cutting, coagulation, debriding, and removal of thin bone and soft tissue in general ENT and Sinus/Rhinology procedures.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
388931
Start Date
May 23, 2022
Effective Date
May 23, 2022
Manufacturer
Country
United States of America
Address
9600 Louisiana Avenue North, Brooklyn Park, MN, 55445