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Sterile ultrasound coupling gel - ARTG 351797

Access comprehensive regulatory information for Sterile ultrasound coupling gel in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 351797 and sponsored by Constar X Pty Ltd, manufactured by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler San ve Tic AS in Turkey. The device registration started on December 16, 2020.

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
ARTG 351797
Class IIa
Sterile ultrasound coupling gel
ARTG ID: 351797
Good Name: Constar X Pty Ltd - Sterile ultrasound coupling gel
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Intended Purpose

to provide a coupling between an ultrasound transducer and the patient, allowing for the emission and reception of ultrasonic waves that pass through the skin during an ultrasound examination

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
351797
Start Date
December 16, 2020
Effective Date
December 16, 2020
Manufacturer
Country
Turkey
Address
Yakuplu Mah Birlik Cad No 32/1 ic Kapi No1 Beylikduzu, Istanbul