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GE LOGIQ P7 / P9 Ultrasound Imaging System - HSA Registration DE0502727

Access comprehensive regulatory information for GE LOGIQ P7 / P9 Ultrasound Imaging 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 DE0502727 and owned by GE Ultrasound Korea Ltd. The device was registered on January 28, 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
DE0502727
GE LOGIQ P7 / P9 Ultrasound Imaging System
HSA Registration Number: DE0502727
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Product Description

The LOGIQ P7/P9 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 • Intraoperative (abdominal, thoracic, vascular) • Transesophageal. Image Acquisition is for diagnostic purposes, including measurements on acquired images.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0502727
Registration Date
January 28, 2019
Retention Due Date
January 27, 2026
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)
Sterile Disposable Endocavity Needle Guide Kits Needle Guide Biopsy Starter Kit Sterile Disposable Endocavity Needle Guide Kits Non-Sterile Reusable Stainless Steel Endocavity Needle Guide 4C-RS E8C-RS 8C-RS 12L-RS Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit 9L-RS C1-5-RS L8-18i-RS ML6-15-RS BE9CS-RS Biopsy Starter Kit Biopsy Starter Kit LOGIQ P7 R3 LOGIQ P9 R3 12S-RS L3-12-RS 6S-RS 3Sc-RS 6Tc-RS Biopsy Starter Kit P8D L3-9i-RS Needle Guide L4-12t-RS L6-12-RS E8Cs-RS L12n-RS Biopsy Starter Kit P2D P6D L10-22-RS Biopsy Starter Kit Needle Guide Biopsy Starter Kit RAB2-6-RS IC9-RS Needle Guide RIC5-9A-RS Needle Guide Biopsy Starter Kit
Model Identifier(s)
E8333JB E8385MJ E8385NA E8387M E8387MA H4000SR H40402LN H40402LS H40402LY H40432LC H40432LE H40432LJ H40442LL H40462LA H40462LF H40462LM H40482LN H42742LH H42742LJ H42872LA H42872LB H44901AB H44901AP H45021RP H45041DL H45551ZE H46222LC H46312LZ H46442LK H46721R H48062AB H48062AC H48062AF H48062AH H48302AA H4830JE H4830JG H48312AH H48392LL H48681GF H48681ML H48681WR H48691PJ H48691YW H48701EJ H48701MN H4906BK