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Philips CareEvent Software and Mobile application - HSA Registration DE0018908

Access comprehensive regulatory information for Philips CareEvent Software and Mobile application in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018908 and owned by Philips Medical Systems. The device was registered on January 23, 2017.

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
DE0018908
Philips CareEvent Software and Mobile application
HSA Registration Number: DE0018908
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Product Description

The intended use of Philips CareEvent is to deliver supplemental medical device data associated with physiological alarms, technical alarms, clinical notifications, nurse call alarms and informational messages to a healthcare professionalโ€™s end device. The user may receive visual or audible notifications, and/or other message notification types based on the communicator in use. Philips CareEvent is a component of a distributed alarming system. It does not generate the alarm, alter the behavior of the alarm-generating system, replace the alarming system that generates the alarms, nor is it intended to provide real-time information, therefore the device producing the alarm or event remains the primary notification system. (Due to system restriction, full intended use is available in IFU)

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0018908
Registration Date
January 23, 2017
Change Notification Approval Date
October 02, 2024
Retention Due Date
January 22, 2026
Product Owner
Short Name
Philips
Address
3000 Minuteman Road, Andover, MA 01810-1099, UNITED STATES
Registrant
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model Information
Model Name(s)
Care Assist Care Assist CareEvent Software Application
Model Identifier(s)
453564549311 453564839101 866435