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Philips Wearable Biosensor - HSA Registration DE0018642

Access comprehensive regulatory information for Philips Wearable Biosensor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018642 and owned by Philips Medical Systems. The device was registered on October 07, 2016.

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
DE0018642
Philips Wearable Biosensor
HSA Registration Number: DE0018642
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Product Description

The Biosensor is a wireless remote sensing device intended for use by healthcare professionals for continuous collection of a patient’s physiological data in home and healthcare settings. This data can include: • Heart Rate • Electrocardiography (ECG) • Skin Temperature • R-R Interval • Respiratory Rate • Patient Activity (including step count) • Posture (body position relative to gravity includingfall detection) • Fall Detection Patient data is transmitted via wireless communication from the Biosensor to its Relay, which transmits the data to a secure server for storage and analysis. The Biosensor is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. Data from the Biosensor is intended for use by healthcare professionals as an aid to patient diagnosis and treatment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0018642
Registration Date
October 07, 2016
Change Notification Approval Date
January 02, 2018
Retention Due Date
October 06, 2025
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)
Philips Wearable Biosensor, Gentle Grade Philips Wearable Biosensor, Active Grade Philips Wearable Biosensor, Hydrocolloid Relay mobile software library
Model Identifier(s)
989803196861 989803196871 989803200061 v2.5.6