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Singapore HSA registration DE0506582

GE LOGIQ E10s / LOGIQ Fortis Ultrasound Systems

Singapore flagSingapore·CLASS B·GE Ultrasound Korea, Ltd.·Registered January 19, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0506582
Registration Date
January 19, 2022
Retention Due Date
January 18, 2026
Product description
The LOGIQ E10s and LOGIQ Fortis are a general purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s and LOGIQ Fortis clinical applications include: Fetal / Obstetrics; Abdominal (including 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 and Intraoperative (Vascular).
Product Owner
Name
GE Ultrasound Korea, Ltd.
Short Name
GE Ultrasound Korea, Ltd.
Address
9, Sunhwan-ro, 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do 13204, KOREA, REPUBLIC OF
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
6S-D IC5-9-D ML6-15-D L8-18I-D C2-9-D C1-6-D L3-12-D M5Sc-D C1-6VN-D C2-9VN-D C3-10-D C2-7-D C2-7VN-D BE9CS-D L2-9-D L2-9VN-D L6-24-D ML4-20-D ML4-20VN-D Needle Guide Biopsy Starter Kit Starter Kit (ML6-15-D) Starter Kit (C3-10-D) Biopsy Starter Kit Biopsy Starter Kit Needle Guide Verza Guidance System Verza Guidance System Biopsy Starter kit Biopsy Starter Kit Biopsy Starter Kit RIC5-9-D RAB6-D Biopsy Starter Kit 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 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 6Tc-RS LOGIQ E10s LOGIQ E10s LOGIQ Fortis LOGIQ Fortis P2D P6D
Model Identifier(s)
47236955 5194434 5199103 5336965 5405253 5418916 5437242 5446812 5476278 5488221 5493011 5505700 5505701 5535372 5745280 5745806 5833059 5838850 5838851 E8385MJ H40432LJ H40432LK H40482LF H40482LK H40482LL H42742LJ H44901AM H44901AV H45561FC H46701AE H48302AA H48651MS H48681MG H48681ML H4908NF H4908NH H4908NM H4910NT H4910NY H4911NG H4913AT H4913BA H4913BB H4913NT H4913NU H4913NV H4913PS H4915MT H4917VB KN100106 LOGIQ E10s R3 LOGIQ E10s R3 OLED LOGIQ Fortis HDU LOGIQ Fortis LCD TE100024 TQ100002 08
About this record

Access comprehensive regulatory information for GE LOGIQ E10s / LOGIQ Fortis Ultrasound Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506582 and owned by GE Ultrasound Korea, Ltd.. The device was registered on January 19, 2022.

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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