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Philips Biosensor BX100 Wearable Biosensor - HSA Registration DE0504674

Access comprehensive regulatory information for Philips Biosensor BX100 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 DE0504674 and owned by Philips Medical Systems. The device was registered on July 06, 2020.

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
DE0504674
Philips Biosensor BX100 Wearable Biosensor
HSA Registration Number: DE0504674
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Product Description

The Philips Biosensor BX100 is a physiological measurement device for use by healthcare professionals to aid in the treatment and management of patient conditions in general care areas of a hospital. The Philips Biosensor BX100 is intended for use by healthcare professionals on patients 18 years of age and older. This chest-worn biosensor collects, stores, and transmits physiological data and contextual parameters to a qualified backend system. Physiological data includes respiration rate and heart rate; contextual parameters include ambulation, activity level, and posture.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504674
Registration Date
July 06, 2020
Retention Due Date
July 05, 2025
Product Owner
Short Name
Philips
Address
3000 Minuteman Road, Andover, Massachusetts 01810-1099, USA, 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 Biosensor BX100
Model Identifier(s)
989803203011