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Singapore HSA registration DE0507821

Cadwell Arc Zenith

Singapore flagSingapore·CLASS B·Cadwell Industries, Inc.·Registered February 24, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0507821
Registration Date
February 24, 2023
Retention Due Date
February 23, 2026
Product description
Zenith is an electroneurodiagnostic device that accepts, measures, displays, records, and stores electrical activity of the brain via scalp and intracranial electroencephalography (EEG) signals, and, utilizing an integrated switch matrix, relays stimulation signals to the patient.
Product Owner
Name
Cadwell Industries, Inc.
Short Name
Cadwell Industries, Inc.
Address
909 N Kellogg St, Kennewick WA 99336, U.S.A., Washington, UNITED STATES
Registrant
Name
MEDSCI RESEARCH & SUPPLY PTE. LTD.
Address
50 SERANGOON NORTH AVENUE 4, FIRST CENTRE, #05-14, SINGAPORE 555856
Importer
Name
MEDSCI RESEARCH & SUPPLY PTE. LTD.
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #07-21, SINGAPORE 159471
Model information
Model Name(s)
Arc Photic Stim Cascade IOMAX Base Module Cascade IOMAX Cortical Module Zenith 144 Channel Amplifier Patient Event Switch 8-Input Touchproof Adapter 12-Input Touchproof Adapter 16-Input Touchproof Adapter Arc Software
Model Identifier(s)
190289-200 190291-200 190296-200 190307-200 199244-200-010 199244-000-025 199297-200 199298-200 199299-200 369045-200
About this record

Access comprehensive regulatory information for Cadwell Arc Zenith in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507821 and owned by Cadwell Industries, Inc.. The device was registered on February 24, 2023.

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