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Shenzhen Wisonic Medical Technology Labat Ultrasonic Diagnostic System - HSA Registration DE0509288

Access comprehensive regulatory information for Shenzhen Wisonic Medical Technology Labat 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 DE0509288 and owned by Shenzhen Wisonic Medical Technology Co., Ltd.. The device was registered on May 14, 2024.

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
DE0509288
Shenzhen Wisonic Medical Technology Labat Ultrasonic Diagnostic System
HSA Registration Number: DE0509288
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Product Description

The Labat series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small organ (breast, thyroid, testes,etc.), neonatal cephalic, adult cephalic, trans-vaginal, trans-rectal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), trans-esoph. (cardiac), peripheral vessel and urology exams. The operator for Labat series Diagnostic Ultrasound System is intended for professional clinical staff or the qualified and trained personnel with experience in the use of ultrasound diagnostic equipment. The device is intended to be used in hospital or clinics. 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, Anatomic M and combined mode.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509288
Registration Date
May 14, 2024
Retention Due Date
May 13, 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 ECG cable ECG cable Laser Marker 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 Ultrasonic Diagnostic System Ultrasonic Diagnostic System Magnetic cup Magnetic cup Ultrasonic Transducer Ultrasonic Transducer Gel warmer
Model Identifier(s)
C6-1B-H C8-3-H EV11-3-H EZCO1401320A EZCO1401320I FU-TSDZ JEM-028 JSM-041 JSM-295 JSM-297 L15-4NB-H L15-4WB-H L15-6-H L22-10-H LH15-6-H LI14I13A Labat SE Labat SP MAG01 MAG02 P7-3T-H SP5-1-H UGW-01