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GE Vivid iq Ultrasound System - HSA Registration DE0510690

Access comprehensive regulatory information for GE Vivid iq Ultrasound 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 DE0510690 and owned by GE Medical Systems (China) Co., Ltd.. The device was registered on May 07, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, 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
DE0510690
GE Vivid iq Ultrasound System
HSA Registration Number: DE0510690
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Product Description

The Vivid iq is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy, Vascular access), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0510690
Registration Date
May 07, 2025
Retention Due Date
May 06, 2026
Product Owner
Short Name
GE Medical Systems (China) Co., Ltd.
Address
No. 19 Changjiang Road, Wuxi National Hi-Tech Dev. Zone, 214028 Jiangsu, CHINA
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model Information
Model Name(s)
8C-RS 6S-RS 12S-RS 3SC-RS 4C-RS 12L-RS 9L-RS C1-5-RS L8-18i-RS ML6-15-RS E8Cs-RS M5Sc-RS 10T-D L4-20t-RS Needle Guide Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit L4-20t Verza biopsy starter kit Biopsy Starter kit Biopsy Starter Kit Biopsy Starter Kit 6Tc-RS 6VT-D 9T-RS P2D Vivid iq
Model Identifier(s)
2354973 47236956 47237175 47237516 5125386 5141337 5212630 5384874 5393197 5428942 5641682 5718483 5772436 5843289 E8385MJ E8385NA H40432LC H40432LE H40432LJ H45201BLF H45561FC H46222LC H4906BK KN100106 KN100120 KN100122 01 TE100024 Vivid iq v208