ARTG 445630Embrace Noenatal MRI System - MRI system, full-body, permanent magnet
ARTG ID: 445630 · Gamma Gurus Pty Ltd · Aspect Imaging Ltd · Class IIa · Started April 10, 2024
Good Name: Gamma Gurus Pty Ltd - Embrace Noenatal MRI System - MRI system, full-body, permanent magnet
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 445630
- Start Date
- April 10, 2024
- Effective Date
- April 10, 2024
- Country
- Israel
- Address
- 27 Shaked Street Industrial Area, Hevel Modi'in, 7319900
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Access comprehensive regulatory information for Embrace Noenatal MRI System - MRI system, full-body, permanent magnet in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 445630 and sponsored by Gamma Gurus Pty Ltd, manufactured by Aspect Imaging Ltd in Israel. The device registration started on April 10, 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.