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GE LOGIQ P8/P9/P10 Ultrasound System - HSA Registration DE0508121

Access comprehensive regulatory information for GE LOGIQ P8/P9/P10 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 DE0508121 and owned by GE Ultrasound Korea, Ltd.. The device was registered on May 24, 2023.

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
DE0508121
GE LOGIQ P8/P9/P10 Ultrasound System
HSA Registration Number: DE0508121
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Product Description

The LOGIQ P8/P9/P10 is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; 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 (abdominal, vascular).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508121
Registration Date
May 24, 2023
Retention Due Date
May 23, 2025
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)
8C-RS 6S-RS 12S-RS 3Sc-RS 12L-RS 9L-RS E8C-RS C1-5-RS L8-18i-RS C1-6-D ML6-15-RS L4-12t-RS L10-22-RS L6-12-RS 10C-D C3-10-D P8D C2-7-D BE9CS-RS E8Cs-RS M5Sc-RS L3-9i-RS L3-12-RS E7C8L-RS Needle Guide Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Needle Guide Needle Guide Biopsy Starter kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Needle Guide Biopsy Starter Kit RAB2-6-RS IC9-RS Needle Guide RIC5-9A-RS Biopsy Starter Kit Biopsy Starter Kit 6Tc-RS LOGIQ P10 LOGIQ P10 LOGIQ P8 LOGIQ P9 P2D P6D
Model Identifier(s)
2354973 47236956 47237175 47237516 5141337 5212630 5318734 5384874 5393197 5418916 5428942 5433596 5441887 5459829 5476030 5493011 5504447 5505700 5589329 5641682 5718483 5721640 5785911 5816913 E8385MJ H40432LC H40432LE H40432LJ H40482LK H40482LL H42742LH H42742LJ H45561FC H46222LC H48302AA H48392LL H48392LT H48681GF H48681ML H48681WR H48691PJ H48691YW H48701EJ H4906BK H4913BB KN100106 LOGIQ P10 R4.5 LOGIQ P10 R4.5 HD LOGIQ P8 R4.5 LOGIQ P9 R4.5 TE100024 TQ100002