Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Constar X Pty Ltd · Karex Industries Sdn Bhd · Class IIa · Started July 17, 2023

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

Device classification

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

Registration information

Start Date: July 17, 2023
Effective Date: July 17, 2023

Sponsor

Name: Constar X 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

A single use transducer cover designed for easy application and fit various ultrasound transducer shapes. Transducer cover is intended to prevent cross contamination of transducer probe suring endocavity (ie transvaginal or transrectal) untrasound procedures.

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 IIa is sponsored by Constar X Pty Ltd, manufactured by Karex Industries Sdn Bhd in Malaysia. The device registration started on July 17, 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.