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Compumedics Okti - HSA Registration DE0508494

Access comprehensive regulatory information for Compumedics Okti in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508494 and owned by Compumedics Limited. The device was registered on September 15, 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.

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CLASS B
DE0508494
Compumedics Okti
HSA Registration Number: DE0508494
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Product Description

The Okti is intended for use in the recording, display, analysis, printing and storage of the electrical activity of a patient's brain or other patient biological parameters such as heart and muscle activity, to assist in the diagnosis of various neurological disorders. Okti is designed for use in a hospital or other controlled environments. Okti is only to be used under the direction of a physician. The data acquired must be interpreted by a qualified physician

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0508494
Registration Date
September 15, 2023
Retention Due Date
September 14, 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)
Okti
Model Identifier(s)
8029-0001-01