Singapore HSA registration DE0018642
Philips Wearable Biosensor
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 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.
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
About this record
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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