Pure Global

Heart-lung bypass system module, detector, air/fluid level - ARTG 316393

Access comprehensive regulatory information for Heart-lung bypass system module, detector, air/fluid level in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 316393 and sponsored by Terumo Australia Pty Ltd, manufactured by Terumo Cardiovascular Systems Corporation in United States of America. The device registration started on April 11, 2019.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 316393
Class I
Heart-lung bypass system module, detector, air/fluid level
ARTG ID: 316393
Good Name: Terumo Australia Pty Ltd - Heart-lung bypass system module, detector, air/fluid level
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Level sensors pads are used to attach the level sensors to a hard shell reservoir to aid in blood level monitoring

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
316393
Start Date
April 11, 2019
Effective Date
April 11, 2019
Manufacturer
Country
United States of America
Address
6200 Jacksons Road, ANN ARBOR, MICHIGAN, 48103