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Shenzhen Wisonic Medical Technology Clivia Ultrasonic Diagnostic System - HSA Registration DE0508545

Access comprehensive regulatory information for Shenzhen Wisonic Medical Technology Clivia Ultrasonic Diagnostic 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 DE0508545 and owned by Shenzhen Wisonic Medical Technology Co., Ltd.. The device was registered on October 05, 2023.

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
DE0508545
Shenzhen Wisonic Medical Technology Clivia Ultrasonic Diagnostic System
HSA Registration Number: DE0508545
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Product Description

The Clivia 90 Ultrasonic Diagnostic 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), Musculoskeletal (Superficial), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric), peripheral vessel and Urology exams. Modes of operation include: B-Mode, M-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, 3D/4D, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M(AMM) and combined modes.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0508545
Registration Date
October 05, 2023
Retention Due Date
October 04, 2025
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 Ultrasonic Diagnostic System Ultrasonic Diagnostic System Ultrasonic Transducer ECG module Ultrasonic Transducer ECG cable ECG cable Mobile Trolley Reusable Needle Guides Reusable Needle Guides Reusable Needle Guides Ultrasonic Transducer Ultrasonic Transducer Ultrasonic Transducer Rechargeable Li-ion Battery Pack Rechargeable Li-ion Battery Pack Magnetic cup Magnetic cup Adapter Ultrasonic Transducer Ultrasonic Transducer Probe Extender Barcode Reader
Model Identifier(s)
C6-1B-H C6-2-H C9-3-H Clivia 90 Clivia 90Exp D7-2-H ECG10 EV11-3-H EZCO1401320A EZCO1401320I G500 JEM-028 JSM-040 JSM-295 L15-4NB-H L22-10-H LH15-6-H LI14I06A-US88 LI14I13A MAG01 MAG02 MANGO150S-19AD-WIS P8-3-H SP5-1-H TEM30 Xenon 1900h