Australia TGA ARTG record

X-ray generator, diagnostic, hand-held

Australia TGA ARTG Registered Device · Wiselink Group Pty Ltd · Changzhou Sifary Medical Technology Co Ltd · Class IIb · Started November 02, 2023

Good Name: Wiselink Group Pty Ltd - X-ray generator, diagnostic, hand-held

Device classification

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

Registration information

Start Date: November 02, 2023
Effective Date: November 02, 2023

Sponsor

Name: Wiselink Group Pty Ltd

Manufacturer

Name: Changzhou Sifary Medical Technology Co Ltd
Country: China
Address: No 99 Qingyang Road Xuejia County Xinbei District, Changzhou City, Jiangsu, 213000

Intended purpose

The HyperLight Hand-held Dental X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. This device must only be used in hospital environments, clinics or dental offices where appropriate safeguards are implemented, and not used in an oxygen-rich environment.

About this record

Access comprehensive regulatory information for X-ray generator, diagnostic, hand-held in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Wiselink Group Pty Ltd, manufactured by Changzhou Sifary Medical Technology Co Ltd in China. The device registration started on November 02, 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.