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Suzhou PeakSonic Medical Technology Peaksonic Bladder Scanner - HSA Registration DE0509110

Access comprehensive regulatory information for Suzhou PeakSonic Medical Technology 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 DE0509110 and owned by Suzhou Peaksonic Medical Technology Co., Ltd.. The device was registered on March 26, 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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CLASS B
DE0509110
Suzhou PeakSonic Medical Technology Peaksonic Bladder Scanner
HSA Registration Number: DE0509110
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Product Description

The bladder scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. The bladder scanner is intended to be used only by qualified medical professionals.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509110
Registration Date
March 26, 2024
Retention Due Date
March 25, 2026
Product Owner
Short Name
Suzhou Peaksonic Medical Technology Co., Ltd.
Address
2A, West Side of Building G4,, Kunshan Hi-Tech Medical Device, Industrial Park, Qiandeng, Kunshan,, Suzhou, Jiangsu 215341, CHINA, 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 PeakSonic Bladder Scanner PeakSonic Bladder Scanner PeakSonic Bladder Scanner Upper computer system PeakSonic M3 PeakSonic M3 HD PeakSonic M4 PeakSonic M4 HD
Model Identifier(s)
M3 M3 HD M4 M4 HD Patient Management System PeakSonic M3 (Android) PeakSonic M3 HD (Android) PeakSonic M4 (Android) PeakSonic M4 HD (Android)