Australia TGA ARTG record

Single-patient physiologic monitoring system

Australia TGA ARTG Registered Device · Epique Biomedical Solutions Pty Ltd · Dixion Vertrieb medizinischer Geräte GmbH · Class IIb · Started April 24, 2024

Good Name: Epique Biomedical Solutions Pty Ltd - Single-patient physiologic monitoring system

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 24, 2024
Effective Date: April 24, 2024

Sponsor

Name: Epique Biomedical Solutions Pty Ltd

Manufacturer

Name: Dixion Vertrieb medizinischer Geräte GmbH
Country: Germany
Address: Couvenstr 6, Düsseldorf, 40211

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.

About this record

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 sponsored by Epique Biomedical Solutions Pty Ltd, manufactured by Dixion Vertrieb medizinischer Geräte 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.