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Philips Capsule Surveillance - HSA Registration DE0509745

Access comprehensive regulatory information for Philips Capsule Surveillance in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509745 and owned by Philips North America LLC. The device was registered on September 06, 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
DE0509745
Philips Capsule Surveillance
HSA Registration Number: DE0509745
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Product Description

Capsule Surveillance is a clinical decision support device that integrates, analyzes, and displays data from multiple sources including medical devices and healthcare information systems. It uses standardized rules that are based on customer-approved clinical practices, protocols, and policies to create clinically relevant alerts in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended to replace cliniciansโ€™ judgment, but rather to assist clinicians in making timely, informed, higher quality decisions. Capsule Surveillance may be configured for secondary monitoring and alerting intended to be relied upon in deciding to take immediate clinical action. Capsule Surveillance may also be configured for remote display of physiological data and alerts not intended to be relied upon in deciding to take immediate clinical action.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509745
Registration Date
September 06, 2024
Retention Due Date
September 05, 2025
Product Owner
Short Name
Philips North America LLC
Address
222 Jacobs Street, Cambridge, MA 02141, 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)
Capsule Surveillance
Model Identifier(s)
Capsule Surveillance