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GE LOGIQ Totus - HSA Registration DE0509138

Access comprehensive regulatory information for GE LOGIQ Totus in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509138 and owned by GE Ultrasound Korea, Ltd.. The device was registered on April 05, 2024.

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
DE0509138
GE LOGIQ Totus
HSA Registration Number: DE0509138
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Product Description

The LOGIQ Totus is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ Totus 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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509138
Registration Date
April 05, 2024
Retention Due Date
April 04, 2026
Product Owner
Short Name
GE Ultrasound Korea, Ltd.
Address
9, Sunhwan-ro, 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do 13204, 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)
6S-D 12S-D 9L-D IC5-9-D ML6-15-D C1-6-D L3-12-D M5Sc-D C1-6VN-D C3-10-D C2-7-D C2-7VN-D L6-24-D Needle Guide Biopsy Starter Kit Starter Kit Starter Kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter kit Biopsy Starter Kit Biopsy Starter Kit RIC5-9-D Needle Guide RAB6-D Biopsy Starter Kit Biopsy Starter Kit Starter Kit Starter Kit Starter Kit 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 Tracker Bracket omniTRAX MR Active Patient Tracker Verza Guidance System LOGIQ Totus LOGIQ Totus P2D P6D
Model Identifier(s)
47236955 47237174 5194432 5194434 5199103 5418916 5437242 5446812 5476278 5493011 5505700 5505701 5833059 E8385MJ H40432LJ H40432LK H40482LF H40482LK H40482LL H45561FC H46701AE H48302AA H48651MS H48681GF H48681MG H48681ML H4906BK H4908NB H4908NF H4908NM H4910NT H4910NY H4911NG H4913AT H4913BB H4913NT H4913NU H4913NV H4913PS H4915MT H4917VB LOGIQ Totus LOGIQ Totus HDU TE100024 TQ100002 08