Singapore HSA registration DE0504382
GE LOGIQ E10s Ultrasound System
Singapore·CLASS B·GE Ultrasound Korea Ltd·Registered April 20, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0504382
- Registration Date
- April 20, 2020
- Retention Due Date
- April 19, 2026
Product description
The LOGIQ E10s is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: • Fetal/Obstetrics • Abdominal (includes Renal, Gynecology/Pelvic) • Pediatric • Small Organ (Breast, Testes, Thyroid) • Neonatal Cephalic • Adult Cephalic • Cardiac (Adult and Pediatric) • Peripheral Vascular • Musculo-skeletal Conventional and Superficial • Urology (including Prostate) • Transrectal • Transvaginal • Transesophageal • Intraoperative (Vascular). Image Acquisition is for diagnostic purposes, including measurements on acquired images.
Product Owner
- Short Name
- Ge Ultrasound Korea Ltd
- Address
- 9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, KOREA, REPUBLIC OF
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)
- Needle Guide Biopsy Starter Kit Starter Kit (ML6-15-D) IC5-9-D ML6-15-D L8-18I-D C2-9-D C1-6-D C1-6VN-D C2-9VN-D C3-10-D BE9CS-D Starter Kit (C3-10-D) Biopsy Starter Kit Biopsy Starter Kit M5Sc-D L2-9-D L2-9VN-D Verza Guidance System 6S-D 6Tc-RS Biopsy Starter kit C2-7-D C2-7VN-D Biopsy Starter Kit L3-12-D Biopsy Starter Kit P2D P6D RIC5-9-D RAB6-D Starter Kit (IC5-9-D) Starter Kit (L8-18i-D) Starter Kit (M5S-D) eTRAX Needle Guidance System Starter Kit Virtual Needle Tracker Virtual Tracker Sensor omniTRAX Active Patient Tracker Biopsy Starter Kit eTRAX 18-20g Starter Kit eTRAX 12 14g Starter Kit eTRAX 14 16g Starter Kit Tracking Bracket omniTRAX MR Active Patient Tracker Verza Guidance System LOGIQ E10s
- Model Identifier(s)
- E8385MJ H40432LJ H40432LK H40442LK H40452LG H40452LL H40462LN H40472LT H40472LW H40472LY H40482LB H40482LE H40482LF H40482LK H40482LL H44901AE H44901AI H44901AJ H44901AM H45021RR H45551ZE H45561FC H46422LM H46422LN H46701AE H48062AA H48302AA H4830JE H4830JG H48651MS H48681MG H4908NF H4908NH H4908NM H4910NT H4910NY H4911NG H4913AT H4913BA H4913NT H4913NU H4913NV H4913PS H4915MT H4917VB LOGIQ E10s
About this record
Access comprehensive regulatory information for GE LOGIQ E10s 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 DE0504382 and owned by GE Ultrasound Korea Ltd. The device was registered on April 20, 2020.
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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