ARTG 446554

Body-orifice ultrasound imaging system transducer cover, basic, sterile

ARTG ID: 446554 · Gytech Pty Ltd · Karex Industries Sdn Bhd · Class Is · Started April 24, 2024

Good Name: Gytech Pty Ltd - Body-orifice ultrasound imaging system transducer cover, basic, sterile

Device classification

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

Registration information

ARTG ID: 446554
Start Date: April 24, 2024
Effective Date: April 24, 2024

Sponsor

Name: Gytech Pty Ltd

Manufacturer

Name: Karex Industries Sdn Bhd
Country: Malaysia
Address: PTD 7906 & 7907 Taman Pontian Jaya Batu 34 Jalan Johor Pontian, Johor, 82000

Intended purpose

Latex and Non Latex protective transducer covers to be used during invasive examinations.

About this record

Access comprehensive regulatory information for Body-orifice ultrasound imaging system transducer cover, basic, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 446554 and sponsored by Gytech Pty Ltd, manufactured by Karex Industries Sdn Bhd in Malaysia. The device registration started on April 24, 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.