Singapore HSA registration DE0014169
Natus Olympic Brainz Monitor
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Neurology
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0014169
- Registration Date
- October 28, 2013
- Change Notification Approval Date
- August 26, 2022
- Retention Due Date
- October 27, 2025
Product description
The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings. - The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain. - The signals acquired from P3-P4 channel is intended to assist in the assessment of Hypoxic-Ischemic Encephalopathy severity and long-term outcome, in full term neonates (post-conceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event. - The RecogniZe seizure detection algorithm is intended to mark sections of EEG/aEEG that may correspond to electrographic seizures in only the centro-parietal regions of full term neonates (defined as from birth to 28 days post-delivery and corresponding to a postconceptual age of 37 to 46 weeks). EEG recordings should be obtained from centro-parietal electrodes (located at P3, P4, C3 and C4 according to 10/20 system). The output of the Recognize algorithm is intended to assist in post hoc assessment of EEG/aEEG traces by qualified clinical practitioners, who will exercise professional judgment in using the information. The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.
Product Owner
- Short Name
- Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
- Address
- 2568 Bristol Circle, Oakville, Ontario, L6H 5S1, CANADA
Registrant
- Address
- 81 TOH GUAN ROAD EAST, SECOM CENTRE, #03-01, SINGAPORE 608606
Importer
- Address
- 81 TOH GUAN ROAD EAST, SECOM CENTRE, #03-01, SINGAPORE 608606 81 TOH GUAN ROAD EAST, #03-01, SINGAPORE 608606
Model information
- Model Name(s)
- NuPrep Gel 102566N Olympic Brainz Monitor DAB OBM00002 Olympic Brainz Monitor OBM00003 OBM Sensor Application Kit OBM Neonatal Hydrogel Sensors OBM00042 Wrap Hat x10 CFM: OBM00043 Skin Marker x10 CFM: OBM00044 Disposable EEG Needle Electrodes OBM00046 OBM Positioning Strips OBM00047 OBM RecogniZe Licence Kit Olympic Brainz Monitor OBM00401 OBM Starter Kit OBM00410 Olympic Brainz Monitor Viewer CD Olympic Brainz Monitor Software Upgrade Version 3.1.5 Olympic Brainz Monitor Kit - UK - OBM70003 Disposable EEG Needle Electrodes PRO-E5
- Model Identifier(s)
- 102566N OBM00002 OBM00003 OBM00041 OBM00042 OBM00043 OBM00044 OBM00046 OBM00047 OBM00092 OBM00401 OBM00410 OBM00461 OBM00462 OBM70003 PRO-E5
About this record
Access comprehensive regulatory information for Natus Olympic Brainz Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014169 and owned by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK). The device was registered on October 28, 2013.
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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