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Suzhou PeakSonic Peaksonic Bladder Scanner - HSA Registration DE0507453

Access comprehensive regulatory information for Suzhou 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 DE0507453 and owned by Suzhou PeakSonic Medical Technology Co., Ltd.. The device was registered on November 08, 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.

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CLASS B
DE0507453
Suzhou PeakSonic Peaksonic Bladder Scanner
HSA Registration Number: DE0507453
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Product Description

The instrument is suitable for the measurement of bladder volume in primary medical units and nursing homes. It provides the basis for the implementation of clinical catheterization and evaluates the residual amount of urine after urination. And it helps to make auxiliary diagnosis for the bladder and kidney function diseases. The instrument is also suitable for people with lower body disability and loss of self urination function to master the time of urination.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507453
Registration Date
November 08, 2022
Change Notification Approval Date
November 14, 2023
Retention Due Date
November 07, 2025
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 Town, Kunshan, Suzhou, 215341 Jiangsu, CHINA
Registrant
Address
2 ANG MO KIO STREET 64, ECON INDUSTRIAL BUILDING, #05-02A, SINGAPORE 569084
Importer
Address
40 JALAN PEMIMPIN, TAT ANN BUILDING, #03-01C, SINGAPORE 577185
Model Information
Model Name(s)
Peaksonic Bladder Scanner Peaksonic Bladder Scanner
Model Identifier(s)
M1 M2