Pure Global

Single-patient physiologic monitoring system - ARTG 446411

Access comprehensive regulatory information for Single-patient physiologic monitoring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 446411 and sponsored by Epique Biomedical Solutions Pty Ltd, manufactured by Dixion Vertrieb medizinischer Gerรคte GmbH in Germany. The device registration started on April 24, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 446411
Class IIb
Single-patient physiologic monitoring system
ARTG ID: 446411
Good Name: Epique Biomedical Solutions Pty Ltd - Single-patient physiologic monitoring system
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

STORM 5110 patient monitor is intended for continuously monitoring or spot checking of SpO2, PR, NIBP signals of single adult, pediatric and neonatal patient.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
446411
Start Date
April 24, 2024
Effective Date
April 24, 2024
Manufacturer
Country
Germany
Address
Couvenstr 6, Dรผsseldorf, 40211