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Nihon Kohden Wireless Input Unit - HSA Registration DE0503157

Access comprehensive regulatory information for Nihon Kohden Wireless Input Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503157 and owned by Nihon Kohden Corporation. The device was registered on May 29, 2019.

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
DE0503157
Nihon Kohden Wireless Input Unit
HSA Registration Number: DE0503157
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Product Description

The WEE-1200 Wireless Input Unit is intended to acquire, store, record, and transmit the cerebral and extracerebral activity for EEG and sleep studies. The device should be used together with Nihon Kohden specified electroencephalograph screen. These data may be used by the clinician in sleep disorder, epilepsies and other related disorders as an aid in diagnosis. The WEE-1200 Wireless Input Unit is designed for use by qualified medical personnel in a medical facility such as a hospital or clinic on all patient populations including adult, neonate, infant, child and adolescent subgroups.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0503157
Registration Date
May 29, 2019
Change Notification Approval Date
May 23, 2023
Retention Due Date
May 28, 2025
Product Owner
Short Name
Nihon Kohden
Address
1-31-4 Nishiochiai,, Shinjuku-ku, Tokyo 161-8560, JAPAN
Registrant
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Importer
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Model Information
Model Name(s)
Mini junction box, JE-922A SpO2 adapter, JL-570T Main unit, MU-120A Software kit, QS-011A SpO2 Probe, TL-051S SpO2 Probe, TL-052S SpO2 Probe, TL-061S SpO2 Probe, TL-062S Finger probe, TL-201T Multi-site probe, TL-220T Multi-site Y Probe, TL-260T SpO2 Probe, TL-271T SpO2 Probe, TL-271T3 SpO2 Probe, TL-272T SpO2 Probe, TL-272T3 SpO2 Probe, TL-273T SpO2 Probe, TL-273T3 SpO2 Probe, TL-274T SpO2 Probe, TL-274T3 Disposable SpO2 probe, TL-535U Finger probe, TL-630T1 Finger probe, TL-630T3 Finger probe, TL-631T1 Finger probe, TL-631T3 Wireless Input Unit, WEE-1200 Telemetry unit, ZB-120A
Model Identifier(s)
JE-922A JL-570T MU-120A QS-011A TL-051S TL-052S TL-061S TL-062S TL-201T TL-220T TL-260T TL-271T TL-271T3 TL-272T TL-272T3 TL-273T TL-273T3 TL-274T TL-274T3 TL-535U TL-630T1 TL-630T3 TL-631T1 TL-631T3 WEE-1200 ZB-120A