Singapore HSA registration DE0508494
Compumedics Okti
Singapore·CLASS B·Compumedics Limited·Registered September 15, 2023Device 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 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
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
About this record
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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