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Natus Medical Natus Quantum EEG System - HSA Registration DE0019231

Access comprehensive regulatory information for Natus Medical Natus Quantum 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 DE0019231 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
DE0019231
Natus Medical Natus Quantum EEG System
HSA Registration Number: DE0019231
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Product Description

The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks®/SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0019231
Registration Date
May 09, 2017
Change Notification Approval Date
October 30, 2019
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)
Natus Quantum Breakout to Base Cable 32ft Natus Quantum Breakout to Base Cable 16ft Natus Quantum Breakout to Breakout Cable Natus Quantum Patient Event Button 5ft Natus Quantum Stimulator Daisy Chain Cable for Breakouts Natus Quantum Base DC Input Y Cable Natus Quantum Stim Input Cable for Nicolet Cortical Stimulator Natus Quantum Patient Event Button 30ft Natus Quantum Breakout Box MAIN Natus Quantum Breakout Box B Natus Quantum Base Unit Natus Quantum Breakout DC Input Cable Natus Quantum Nonin Oximeter Adapter Cable Natus Quantum Breakout Main Natus Quantum Breakout Box Natus Quantum Pin Box 1-64 Natus Quantum Pin Box 65-128 Natus Quantum Pin Box 129-192 Natus Quantum Pin Box 193-256 Quantum Modular Pouch Quantum Belt Quantum Harness Quantum Electrode Sleeve Natus Quantum Reference Jumper Cable for Breakouts Quantum Bulk Connector Pin Box 1-64 for Breakout MAIN Quantum Bulk Connector Pin Box 65-128 for Breakout MAIN Quantum Bulk Connector Pin Box 129-192 for Breakout B Quantum Bulk Connector Pin Box 193-256 for Breakout B Natus Base Unit (2nd Gen.) Natus Quantum Breakout Box 1 with memory Natus Quantum Breakout Box 2 with memory Natus Quantum Breakout Box 1 w/Memory Natus Quantum Breakout Box 2 w/Memory Quantum 10-10/10-20 Pin Box Quantum breakout Roll stand Quantum 10-10/10-20 Pin-bix Pouch Neuroworks/Sleepworks 8.4.0.1531 GMA2 DVD (INTL) Natus Quantum Pin Box 0 Quantum 64 breakout Natus Quantum 2nd gen. 128ch breeakout Add-on kit for Natus base 2nd gen. Natus Quantum 2nd gen. 256ch breakouts Add-on kit for Natus base 2nd gen. Natus Quantum 64-channel Breakout Quantum (Phase II) 64-channel Breakout Natus Quantum 64 Breakout Box with memory Software • NeuroWorks/SleepWorks 9.1.0 Photic Stimulator USB 2.0 Hi-Speed Gold Cable 15ft                        Natus Quantum LTM Amplifier - 128ch Natus Quantum LTM Amplifier - 256ch Natus Quantum 128ch Amplifier w/ memory Natus Quantum 256ch Amplifier w/ memory Natus Quantum LTM Amplifier - 64 channels Natus Quantum 64ch Amplifier with memory Long Cable Kit for Tech Room Video/Audio EMU40EX / Brain Monitor Breakout Cable 30ft USB 2.0 Hi-Speed Gold Cable 6ft
Model Identifier(s)
013348 013414 013415 013762 013769 013790 013833 013891 013922 013923 013926 013930 013931 014160 014161 014162 014163 014164 014165 014364 014365 014366 014808 014883 016269 016270 016271 016278 016862 016863 016864 016867 016868 017048 017264 018980 019997 021332 021338 021672-9 021676-9 022134 024229 024230 024494 10440 105513 PK1170 PK1171 PK1173 PK1174 PK1256 PK1258 VID-AUD-LNGCBL-KIT W6438H W8194X