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Wuxi Hisky Shear Wave Quantificational Ultrasound Diagnostic System, Pro9000 - HSA Registration DE0509886

Access comprehensive regulatory information for Wuxi Hisky Shear Wave Quantificational Ultrasound Diagnostic System, Pro9000 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509886 and owned by Wuxi Hisky Medical Technologies Co., Ltd.. The device was registered on October 08, 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
DE0509886
Wuxi Hisky Shear Wave Quantificational Ultrasound Diagnostic System, Pro9000
HSA Registration Number: DE0509886
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Product Description

Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, isintended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509886
Registration Date
October 08, 2024
Retention Due Date
October 07, 2025
Product Owner
Short Name
Wuxi Hisky Medical Technologies Co., Ltd.
Address
Room B401, 530 Plaza, University Science Park, Taihu International Science &, Technology Park, Wuxi 214135, Jiangsu, CHINA
Registrant
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Importer
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Model Information
Model Name(s)
Power cord Main unit Foot switch Fuse Protective earth wire Fibrosis scanning probe Imaging probe
Model Identifier(s)
HO5VV-F Pro9000 TFS-201KD-2BWP-L UDA V0020A XW-01 YD-CX