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Body-orifice ultrasound imaging system transducer cover, basic, sterile - ARTG 446554

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.

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TGA ARTG Official Data
Class Is
ARTG 446554
Class Is
Body-orifice ultrasound imaging system transducer cover, basic, sterile
ARTG ID: 446554
Good Name: Gytech Pty Ltd - Body-orifice ultrasound imaging system transducer cover, basic, sterile
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Intended Purpose

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

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