Singapore HSA registration DE0503988
Nihon Kohden Neuropack S3 EMG/EP Measuring System
Singapore·CLASS C·Nihon Kohden Corporation·Registered January 03, 2020Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0503988
- Registration Date
- January 03, 2020
- Change Notification Approval Date
- January 05, 2021
- Retention Due Date
- January 02, 2026
Product description
The Nihon Kohden Neuropack S3 EMG/EP Measuring System is intended to monitor, record and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), electromyography (EMG), skin temperature of distal portion of extremities to provide health care professionals with information to help assess a patient's neurological status.
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)
- Main unit 2ch Headphones 2ch Headphones GG-961BK GG-962BK JB-962B JB-964B LS-102J EMG/EP Measuring System EEG needle electrode Disposable needle electrode Disposable needle electrode Concentric needle electrode Concentric macro EMG electrode Concentric needle electrode Concentric needle electrode Bipolar needle electrode Bipolar needle electrode Concentric needle electrode Concentric needle electrode Corkscrew electrode Single fiber macro EMG electrode Single fiber electrode Disposable needle electrode Monopolar needle electrode Monopolar needle electrode Monopolar needle electrode QS-010BK RY-230B RY-441B RY-960B Power Unit Power Unit SC-900B Power Unit VD-403B YE-103J
- Model Identifier(s)
- DC-960B DR-531B-14 DR-531B-15 GG-961BK GG-962BK JB-962B JB-964B LS-102J MEB-9600 NE-224S NM-030T NM-050T NM-121T NM-130S NM-131T NM-151T NM-220T NM-250T NM-320T NM-330T NM-480B NM-640S NM-640T NM-715S NM-730S NM-830S NM-850S QS-010BK RY-230B RY-441B RY-960B SC-230B SC-230BK SC-900B SC-900BK VD-403B YE-103J
About this record
Access comprehensive regulatory information for Nihon Kohden Neuropack S3 EMG/EP Measuring System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503988 and owned by Nihon Kohden Corporation. The device was registered on January 03, 2020.
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 DatabasePowered by Pure Global AIHSA Official DataCLASS C