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GE LOGIQ S8 Ultrasound System - HSA Registration DE0503397

Access comprehensive regulatory information for GE LOGIQ S8 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 DE0503397 and owned by GE Ultrasound Korea Ltd. The device was registered on July 24, 2019.

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
DE0503397
GE LOGIQ S8 Ultrasound System
HSA Registration Number: DE0503397
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Product Description

The LOGIQ S8 is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: • Fetal/Obstetrics • Abdominal (includes renal, GYN/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 (abdominal, thoracic, vascular). Image Acquisition is for diagnostic purposes, including measurements on acquired images.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0503397
Registration Date
July 24, 2019
Retention Due Date
July 23, 2025
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 Sterile Disposable Endocavity Needle Guide Kits Non-Sterile Reusable Stainless Steel Endocavity Needle Guide Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Starter Kit Biopsy Starter Kit Starter Kit 11L-D IC5-9-D 9L-D Biopsy Starter Kit C1-5-D ML6-15-D Starter Kit L8-18i-D 3CRF RU Multi Biopsy Kit 3CRF-D C2-9-D C1-6-D C1-6VN-D C2-9VN-D C3-10-D BE9CS-D Starter Kit Starter Kit Biopsy Starter Kit Biopsy Starter Kit Starter Kit M5Sc-D 6S-D S4-10-D M5S-D 6Tc-RS P8D C2-6b-D Integrated Needle Guide Starter Kit 10C-D C2-7-D C2-7VN-D LOGIQ S8 R4 LCD LOGIQ S8 R4 OLED Biopsy Starter Kit Needle Guide L3-12-D Biopsy Starter Kit P2D P6D RSP6-16-D RIC5-9-D 3SP-D RAB6-D Biopsy Starter Kit Biopsy Starter Kit Starter Kit Starter Kit Starter Kit Starter Kit Starter Kit Starter Kit Biopsy Starter Kit eTRAX Needle Guidance System Starter Kit Virtual Needle Tracker Virtual Tracker Sensor omniTRAX Active Patient Tracker Biopsy Starter Kit Biopsy Starter Kit Starter Kit Starter Kit eTRAX Storage Insert Kit eTRAX 18-20g Starter Kit eTRAX 12 14g Starter Kit eTRAX 14 16g Starter Kit Tracking Bracket S1-5-D L3-9i-D omniTRAX MR Active Patient Tracker
Model Identifier(s)
E8385MJ E8387M E8387MA H40412LN H40432LC H40432LE H40432LF H40432LJ H40432LK H40432LN H40442LK H40442LM H40442LR H40452LE H40452LG H40452LK H40452LL H40452LP H40462LK H40462LN H40472LT H40472LW H40472LY H40482LB H40482LE H40482LF H40482LH H40482LK H40482LL H40482LM H44901AE H45021RR H45302LA H45551NH H45551ZE H46312LZ H46332LW H46332LY H46332LZ H46342LA H46422LM H46422LN H46602LG H46602LN H46701AD H46721R H48062AA H48302AA H4830JE H4830JG H48651MR H48651MS H48681AZ H48681MG H48681ML H4906BK H4908NB H4908ND H4908NF H4908NH H4908NM H4908NN H4908SD H4910NT H4910NY H4911NG H4913AT H4913BA H4913BB H4913NK H4913NL H4913NS H4913NT H4913NU H4913NV H4913PS H4913SD H4915IO H4915MT