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Natus Medical XLTEK EEG System - HSA Registration DE0019232

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.

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CLASS B
DE0019232
Natus Medical XLTEK EEG System
HSA Registration Number: DE0019232
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Product Description

The XLTEK EEG System is an electroencephalograph that works in conjunction with Natus NeuroWorksโ„ข 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.

Device 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 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