Singapore HSA registration DE0509288
Shenzhen Wisonic Medical Technology Labat Ultrasonic Diagnostic System
Singapore·CLASS B·Shenzhen Wisonic Medical Technology Co., Ltd.·Registered May 14, 2024Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B