Singapore HSA registration DE0508844
PeakSonic PeakSonic Bladder Scanner
Singapore·CLASS B·Suzhou Peaksonic Medical Technology Co., Ltd.·Registered January 10, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0508844
- Registration Date
- January 10, 2024
- Retention Due Date
- January 09, 2026
Product description
The device projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder. Those images are then used to calculate bladder volume and bladder wall thickness. The instrument is intended to be used only by qualified medical professionals.
Product Owner
- Short Name
- Suzhou Peaksonic Medical Technology Co., Ltd.
- Address
- 2A, West Side of Building G4,, Kunshan Hi-Tech Medical Device,, Industrial Park No.999 Qujia Road,, Qiandeng Town, Kunshan, Su Zhou, Jiang Su, CHINA
Registrant
- Address
- 81 TOH GUAN ROAD EAST, SECOM CENTRE, #03-01, SINGAPORE 608606
Importer
- Address
- 81 TOH GUAN ROAD EAST, SECOM CENTRE, #03-01, SINGAPORE 608606
Model information
- Model Name(s)
- PeakSonic Bladder Scanner
- Model Identifier(s)
- M5
About this record
Access comprehensive regulatory information for PeakSonic PeakSonic Bladder Scanner in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508844 and owned by Suzhou Peaksonic Medical Technology Co., Ltd.. The device was registered on January 10, 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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