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Shenzhen Wisonic Medical Technology Piloter Ultrasonic Diagnostic System - HSA Registration DE0508040

Access comprehensive regulatory information for Shenzhen Wisonic Medical Technology Piloter 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 DE0508040 and owned by Shenzhen Wisonic Medical Technology Co., Ltd.. The device was registered on April 26, 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
DE0508040
Shenzhen Wisonic Medical Technology Piloter Ultrasonic Diagnostic System
HSA Registration Number: DE0508040
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Product Description

The ultrasonic diagnostic system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in the abdomen (liver, spleen, gallbladder, pancreas, kidney), obstetrics and Gynecology, small organs (thyroid and parathyroid gland, testis, prostate, breast, salivary gland, superficial lymph), and peripheral blood vessels, heart and vaginal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0508040
Registration Date
April 26, 2023
Retention Due Date
April 25, 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 Ultrasonic Transducer Mobile trolley Reusable Needle Guides Reusable Needle Guides Reusable Needle Guides Reusable Needle Guides Reusable Needle Guides Ultrasonic Transducer Ultrasonic Transducer Ultrasonic Transducer Magnetic cup Magnetic cup Adapter Ultrasonic Transducer Ultrasonic Transducer Ultrasonic Diagnostic System Ultrasonic Diagnostic System Probe extender
Model Identifier(s)
C5-2 C5-2B C8-3 EV10-4 G60 JEM-028 JSM-020 JSM-032 JSM-050 JSM-059 L10-5 L15-4NB LH15-6 MAG01 MAG02 MANGO60-19AB-WIS P4-1 P7-3 Piloter Piloter Exp TEM10