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Cardioplegia solution administration kit

Access comprehensive regulatory information for Cardioplegia solution administration kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Terumo Australia Pty Ltd, manufactured by Terumo Europe NV in Belgium. The device registration started on March 12, 2014.

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
Cardioplegia solution administration kit
Australia TGA ARTG Registered Device
Good Name: Terumo Australia Pty Ltd - Cardioplegia solution administration kit
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Intended Purpose

A packaged collection of items (such as tubing, a filter, a heat exchanger) intended to cool or warm oxygenated blood, cardioplegia solution, or their mixture during cardiopulmonary bypass surgery for a period of up to 6 hours

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 12, 2014
Effective Date
March 12, 2014
Manufacturer
Country
Belgium
Address
Interleuvenlaan 40, Leuven, 3001