Singapore HSA registration DE0509348
ViVest PowerBeat X Series Automated External Defibrillator
Singapore·CLASS C·ViVest Medical Technology Co., Ltd.·Registered June 04, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0509348
- Registration Date
- June 04, 2024
- Change Notification Approval Date
- September 17, 2024
- Retention Due Date
- June 03, 2025
Product description
PowerBeat X Series Automated External Defibrillator is indicated for use on patients with suspected Sudden Cardiac Arrest (SCA) who are unconscious, unresponsive and not breathing or breathing abnormally. The device can be used for adult or pediatric patients. For patients under 8 years of age or less than 25kg, use pediatric mode. If the age or weight of the patient is uncertain, do not delay the treatment, use adult mode. The device is intended for use by responders who have been trained in its operation and in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program, or it can be used under the guidance of emergency center’s dispatcher.
Product Owner
- Short Name
- ViVest Medical Technology Co., Ltd.
- Address
- Unit 205, 206, 207, B1 Building, SIP BioBay No. 218, Xinghu Street, Suzhou Industrial Park, Suzhou Area, Suzhou Free Trade Pilot Zone 215123, CHINA
Registrant
- Address
- 203 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #12-13, SINGAPORE 159546
Importer
- Address
- 625 ALJUNIED ROAD, ALJUNIED INDUSTRIAL COMPLEX, #04-05A, SINGAPORE 389836
Model information
- Model Name(s)
- PowerBeat X1 PowerBeat X3
- Model Identifier(s)
- X1 X3
About this record
Access comprehensive regulatory information for ViVest PowerBeat X Series Automated External Defibrillator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509348 and owned by ViVest Medical Technology Co., Ltd.. The device was registered on June 04, 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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