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Closed System Transfer Device (CSTD) - Medication transfer set

Access comprehensive regulatory information for Closed System Transfer Device (CSTD) - Medication transfer set in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Aria Healthcare Pty Ltd, manufactured by Shandong Ande Healthcare Apparatus Co Ltd in China. The device registration started on February 09, 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 Is
Class Is
Closed System Transfer Device (CSTD) - Medication transfer set
Australia TGA ARTG Registered Device
Good Name: Aria Healthcare Pty Ltd - Closed System Transfer Device (CSTD) - Medication transfer set
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Intended Purpose

The device is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The system also prevents microbial ingress.

Device Classification
Risk Class
Class Is
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
February 09, 2024
Effective Date
February 09, 2024
Manufacturer
Country
China
Address
No 999 Zunxian Road New & Hi-Tech Zone Zibo, Shandong, 255086