Pure Global

Nihon Kohden EEG Head Set AE-120A - HSA Registration DE0503799

Access comprehensive regulatory information for Nihon Kohden EEG Head Set AE-120A in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503799 and owned by Nihon Kohden Corporation. The device was registered on November 08, 2019.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0503799
Nihon Kohden EEG Head Set AE-120A
HSA Registration Number: DE0503799
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The AE-120A EEG Head Set is intended to amplify, capture and wirelessly transmit electrical activity of the brain for review by a trained medical professional using Nihon Kohden electroencephalograph systems to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition. The device is intended for use by trained medical professionals in a medical facility such as a physician's office, laboratory or clinic. The device is intended for use on adults (ages 18 and above).

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0503799
Registration Date
November 08, 2019
Change Notification Approval Date
May 23, 2023
Retention Due Date
November 07, 2025
Product Owner
Short Name
Nihon Kohden
Address
1-31-4 Nishiochiai,, Shinjuku-ku, Tokyo 161-8560, JAPAN
Registrant
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Importer
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Model Information
Model Name(s)
AE-120A AE-920P
Model Identifier(s)
AE-120A AE-920P