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Cadwell ARC Essentia EEG System - HSA Registration DE0019092

Access comprehensive regulatory information for Cadwell ARC Essentia 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 DE0019092 and owned by Cadwell Industries, Inc.. The device was registered on March 23, 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
DE0019092
Cadwell ARC Essentia EEG System
HSA Registration Number: DE0019092
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Product Description

Cadwell Arc Systems are indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) studies of patients of all ages.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0019092
Registration Date
March 23, 2017
Retention Due Date
March 22, 2026
Product Owner
Short Name
Cadwell Industries, Inc.
Address
909 N Kellogg St, Kennewick WA 99336, U.S.A., Washington, UNITED STATES
Registrant
Address
50 SERANGOON NORTH AVENUE 4, FIRST CENTRE, #05-14, SINGAPORE 555856
Importer
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #07-21, SINGAPORE 159471
Model Information
Model Name(s)
ARC Photic Stimulator ARC Essentia EEG Amplifier ARC Essentia EEG Amplifier ARC Essentia EEG Amplifier Essentia Remote Input Box Oximeter, USB 3012LP Patient Event Switch ARC Software V2.0
Model Identifier(s)
190289-200 190290-00E1 190290-00E2 190290-00E3 190294-200 198232-200 199244-200 369045-200