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Compumedics Grael PSG/EEG System - HSA Registration DE0017394

Access comprehensive regulatory information for Compumedics Grael PSG/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 DE0017394 and owned by Compumedics Limited. The device was registered on August 11, 2015.

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
DE0017394
Compumedics Grael PSG/EEG System
HSA Registration Number: DE0017394
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Product Description

The Grael is intended for use in the recording, dsiplaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assit in the diagnosis of various sleep disorders or neurological disorder.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0017394
Registration Date
August 11, 2015
Retention Due Date
August 10, 2025
Product Owner
Short Name
Compumedics Limited
Address
30-40 Flockhart Street, Abbotsford, Victoria, 3067, AUSTRALIA
Registrant
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #08-12, SINGAPORE 159557
Importer
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #08-12, SINGAPORE 159557
Model Information
Model Name(s)
Grael PSG/EEG System
Model Identifier(s)
9028-0001-01