Pure Global

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

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Body-orifice ultrasound imaging system transducer cover, basic, sterile
Australia TGA ARTG Registered Device
Good Name: Constar X Pty Ltd - Body-orifice ultrasound imaging system transducer cover, basic, sterile
Pure Global
DJ Fang

DJ Fang

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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.

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
Manufacturer
Country
Malaysia
Address
PTD 7906 & 7907 Taman Pontian Jaya Batu 34 Jalan Johor Pontian, Johor, 82000