Singapore HSA registration DE0507343
Bio-Beat Biobeat Medical Smartmonitoring
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0507343
- Registration Date
- October 04, 2022
- Retention Due Date
- October 03, 2025
Product description
BB-613WP is indicated for measurement, spot- checking monitoring, displaying, and storage of biophysical parameters as an adjunct in the assessment of cardiovascular and respiratory status. Indications for use: Blood oxygen saturation, pulse rate, non-invasive blood pressure, cardiac output, stroke volume, respiratory rate, skin temperature, one lead EKG (patch only), mean arterial pressure, pulse pressure, systemic vascular resistance, cardiac index, and pulse rate variability. To be used in healthcare facilities by clinical professionals or under their guidance, or in patient’s home under clinician’s guidance. It is NOT designed to be used in life support situations. BB-613W/P is indicated for adult (+18) patients in hospitals, clinics, long-term care, and home use. BB-613P is also intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. BB-613P ECG is not intended for automated diagnosis.
Product Owner
- Short Name
- Bio-Beat Technologies Ltd.
- Address
- 26 Hamagshimim Street, Petach Tikva 4934835, ISRAEL
Registrant
- Address
- 11 LORONG 3 TOA PAYOH, BLOCK B JACKSON SQUARE, #01-13, SINGAPORE 319579
Importer
- Address
- 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
Model information
- Model Name(s)
- Chest-monitor Sticker (Adhesive) Unit Biobeat Chest-monitor Sticker (Adhesive) Units Biobeat Wrist Monitor Model BB-613W Biobeat Chest-monitor Sensors ABPM Blood Pressure Monitoring Kit Hospital at Home Monitoring Kit Biobeat Web Monitoring Management Platform Mobile Application Android : Biobeat ABPM Mobile Application Android: Biobeat Hospital at Home Chest Mobile Application Android: Biobeat Hospital at Home Wrist Mobile Application iOS : Biobeat ABPM Mobile Application iOS : Biobeat Hospital at Home Chest Mobile Application iOS : Biobeat Hospital at Home Wrist
- Model Identifier(s)
- BB10900200201 BB10900200202 BB90000100000 BB90000200001 BB90000200002 BB90000200003 Biobeat Web Monitoring Management Platform Mobile Application Android : Biobeat ABPM Mobile Application Android: Biobeat Hospital at Home Chest Mobile Application Android: Biobeat Hospital at Home Wrist Mobile Application iOS : Biobeat ABPM Mobile Application iOS : Biobeat Hospital at Home Chest Mobile Application iOS : Biobeat Hospital at Home Wrist
About this record
Access comprehensive regulatory information for Bio-Beat Biobeat Medical Smartmonitoring in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507343 and owned by Bio-Beat Technologies Ltd.. The device was registered on October 04, 2022.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B