Australia TGA ARTG recordPoly-Spectrum-8/EX ECG - Interpretive multichannel electrocardiograph
Australia TGA ARTG Registered Device · AIMedical International Pty Ltd · Neurosoft LLC · Class IIa · Started January 12, 2024
Good Name: AIMedical International Pty Ltd - Poly-Spectrum-8/EX ECG - Interpretive multichannel electrocardiograph
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- Start Date
- January 12, 2024
- Effective Date
- January 12, 2024
- Name
- Neurosoft LLC
- Country
- Russia
- Address
- 5 Voronin Str, Ivanovo, 153032
The Poly-Spectrum-8/EX digital system is intended for acquisition of electrocardiogram and respiratory rate data at rest and during physical exercise and functional tests with automatic QRS-complex detection, measurement of amplitude and duration of ECG waves and intervals, heart rate variability and exercise stress test analysis. The target population for the systems includes all ages.
Access comprehensive regulatory information for Poly-Spectrum-8/EX ECG - Interpretive multichannel electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by AIMedical International Pty Ltd, manufactured by Neurosoft LLC in Russia. The device registration started on January 12, 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.