HSA · registration DE0510715Shenzhen Wisonic Medical Technology Carnation Diagnostic Ultrasound System
- Registration number
- DE0510715
- Model name
- 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
- 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
- Registration date
- May 13, 2025
- Risk class
- Class B
- Product owner
- Shenzhen Wisonic Medical Technology Co., Ltd.
- Registrant / registration holder
- EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
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.
- Product owner address
- 1st, 2nd, 5th & 6th Floor, No.6 Building, Pingshan, Technology Park, Taoyuan Street, Nanshan District, 518055, Shenzhen, China
- Registrant address
- 1 HARBOURFRONT PLACE, #11-01-03, HARBOURFRONT TOWER ONE, Singapore 098633
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.