Singapore HSA registration DE0503799
Nihon Kohden EEG Head Set AE-120A
Singapore·CLASS B·Nihon Kohden Corporation·Registered November 08, 2019Device 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 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).
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
About this record
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.
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