Australia TGA ARTG record

Camera, video endoscopic

Australia TGA ARTG Registered Device · Hologic (Australia & New Zealand) Pty Ltd · Santa Barbara Imaging Systems Inc · Class I · Started August 31, 2023

Good Name: Hologic (Australia & New Zealand) Pty Ltd - Camera, video endoscopic

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: August 31, 2023
Effective Date: August 31, 2023

Sponsor

Name: Hologic (Australia & New Zealand) Pty Ltd

Manufacturer

Name: Santa Barbara Imaging Systems Inc
Country: United States of America
Address: Suite 101 340 Storke Road, Goleta, CA, 93117

Intended purpose

The Camera System, with integrated LED light source and image/video capture, is to be used when performing a variety of minimally invasive surgical procedures and for general medical visualization and video archive applications. The Camera System is intended to be used in a controlled operating room environment with compatible devices by qualified medical personnel.

About this record

Access comprehensive regulatory information for Camera, video endoscopic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Hologic (Australia & New Zealand) Pty Ltd, manufactured by Santa Barbara Imaging Systems Inc in United States of America. The device registration started on August 31, 2023.

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.