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General laboratoryware IVDs - ARTG 461293

Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 461293 and sponsored by ITL Australia Pty Ltd, manufactured by ITL Asia Pacific Sdn Bhd in Malaysia. The device registration started on August 29, 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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Class I
ARTG 461293
Class I
General laboratoryware IVDs
ARTG ID: 461293
Good Name: ITL Australia Pty Ltd - General laboratoryware IVDs
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Intended Purpose

TCS is intended to aid sterile transfer of fluids between blood culture bottles and vacuum tubes for in-vitro tests. Single use only. The device is for use by trained laboratory staff, in a laboratory.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
461293
Start Date
August 29, 2024
Effective Date
August 29, 2024
Manufacturer
Country
Malaysia
Address
Plot 17B Lorong Bemban 2 Bemban Industrial Estate, Batu Gajah, Perak, 31000