Singapore HSA registration DE0019232
Natus Medical XLTEK EEG System
Singapore·CLASS B·Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)·Registered May 09, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0019232
- Registration Date
- May 09, 2017
- Change Notification Approval Date
- February 26, 2024
- Retention Due Date
- May 08, 2026
Product description
The XLTEK EEG System is an electroencephalograph that works in conjunction with Natus NeuroWorks™ software. XLTEK EEG systems are used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.
Product Owner
- Short Name
- Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
- Address
- 2568 Bristol Circle, Oakville, Ontario, L6H 5S1 Canada, CANADA
Registrant
- Address
- 8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Importer
- Address
- 8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Model information
- Model Name(s)
- XLTEK EMU40EX Battery Pack XLTEK EMU40EX Base Unit XLTEK EMU40EX Patient Breakout XLTEK TrexHD Video Interface XLTEK TrexHD Nonin LP Trex Cable XLTEK Sleep/EEG Breakout Neuroworks/Sleepworks 8.4.0.1531 GMA2 DVD (INTL) Xltek Brain Monitor XLTEK EEG32U Photic Stimulator Nonin Pulse Oximeter Kit Nonin Reusable SPo2 Soft Sensor - Medium 3m Embla 8000J XLTEK Patient Event Button - 8' Lemo Patient Call Cord 2'
- Model Identifier(s)
- 002876 006550 006562 007741 008043 010382 012378 019997 10388 10399 10440 105005 105592 1431000 W6232H W6348H
About this record
Access comprehensive regulatory information for Natus Medical XLTEK EEG System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019232 and owned by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK). The device was registered on May 09, 2017.
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 B