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Philips eCareManager - HSA Registration DE0509921

Access comprehensive regulatory information for Philips eCareManager in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509921 and owned by Philips Medical Systems Nederland BV. The device was registered on October 16, 2024.

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 C
DE0509921
Philips eCareManager
HSA Registration Number: DE0509921
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Product Description

The eCareManager System is a software tool intended for use by trained clinical staff providing supplemental remote support to bedside care teams in the management and care of hospital inpatients. The software collects, stores, and displays clinical data obtained from the electronic medical record, patient monitoring systems, and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated which aid in understanding the patientโ€™s current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgment of a medical and/or nursing professional and are not intended to be the sole source of information for decision making.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509921
Registration Date
October 16, 2024
Retention Due Date
October 15, 2025
Product Owner
Short Name
Philips Medical Systems Nederland BV
Address
High Tech Campus 36, 5656 AE Eindhoven, NETHERLANDS
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)
eCareManager
Model Identifier(s)
865325