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Shenzhen Wisonic Medical Technology Carnation Diagnostic Ultrasound System - HSA Registration DE0510715

Access comprehensive regulatory information for Shenzhen Wisonic Medical Technology Carnation Diagnostic Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510715 and owned by Shenzhen Wisonic Medical Technology Co., Ltd.. The device was registered on May 13, 2025.

This page provides complete registration details including product owner information, registrant details, 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
DE0510715
Shenzhen Wisonic Medical Technology Carnation Diagnostic Ultrasound System
HSA Registration Number: DE0510715
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Product Description

The Carnation series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, abdominal/GYN, pediatrics, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans- vaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vessel, urology, Thoracic/Pleural, Vascular Access exams. It is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals in clinical environments including critical care, emergency room environments and point-of-care areas in office, clinical and hospital settings for diagnosis of patients. Modes of operation include: B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M- mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0510715
Registration Date
May 13, 2025
Retention Due Date
May 12, 2026
Product Owner
Short Name
Shenzhen Wisonic Medical Technology Co., Ltd.
Address
1st, 2nd, 5th & 6th Floor, No.6 Building, Pingshan, Technology Park, Taoyuan Street, Nanshan District, 518055, Shenzhen, CHINA
Registrant
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Model Information
Model Name(s)
Ultrasonic Transducer Ultrasonic Transducer Ultrasonic Transducer Diagnostic Ultrasound System Diagnostic Ultrasound System Diagnostic Ultrasound System Ultrasonic Transducer ECG cable ECG cable Foot switch Reusable Needle Guides Reusable Needle Guides Reusable Needle Guides Reusable Needle Guides Ultrasonic Transducer Ultrasonic Transducer Ultrasonic Transducer Ultrasonic Transducer Ultrasonic Transducer Rechargeable Li-ion Battery Pack Magnetic cup Magnetic cup Ultrasonic Transducer Ultrasonic Transducer Ultrasonic Transducer
Model Identifier(s)
C6-1B-H C6-2-H C8-3-H Carnation Exp Carnation Fast Carnation T EV11-3-H EZC01401320A EZC01401320I HRF-M52-U JEM-028 JSM-295 JSM-296 JSM-297 L15-4NB-H L15-4WB-H L15-6-H L22-10-H L8-3-H LI14I13A MAG01 MAG02 P12-4-H P8-3-H SP5-1-H