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Rigid reconstructive surgery endoscope

Access comprehensive regulatory information for Rigid reconstructive surgery endoscope in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Terumo Australia Pty Ltd, manufactured by Terumo Cardiovascular Systems Corporation in United States of America. The device registration started on May 07, 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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Class IIa
Class IIa
Rigid reconstructive surgery endoscope
Australia TGA ARTG Registered Device
Good Name: Terumo Australia Pty Ltd - Rigid reconstructive surgery endoscope
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Intended Purpose

The Endoscope is intended to be used with the VirtuoSaph Plus Endoscopic Vessel Harvesting (EVH) System. The VirtuoSaph Plus EVH System is indicated for use in minimally invasive surgery allowing access for vessel harvesting and is indicated for adult patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery and peripheral artery bypass. The radial artery is only used for coronary artery bypass.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 07, 2024
Effective Date
May 07, 2024
Manufacturer
Country
United States of America
Address
125 Blue Ball Road, Elkton, Maryland, 21921