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GE LOGIQ P9/P7 Ultrasound System - HSA Registration DE0017522

Access comprehensive regulatory information for GE LOGIQ P9/P7 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 DE0017522 and owned by GE Ultrasound Korea Ltd. The device was registered on October 01, 2015.

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
DE0017522
GE LOGIQ P9/P7 Ultrasound System
HSA Registration Number: DE0017522
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Product Description

Specific clinical applications and exam types include: • Obstetrics/Gynecology (includes Fetal echo, Transvaginal) • Abdominal (includes Renal, Chest) • Pediatrics (Ped abd, Ped Hip) • Small Organ ( Breast, Thyroid, Scrotum) • Neonatal (Neo head, Neo abd) • Cardiac (Adult echo, Pediatrics echo) • Peripheral Vascular(Carotid, UEA, UEV, LEA, LEV) • Muscular-Skeletal • Urology (includes Prostate) • Transrectal Image Acquisition is for diagnostic purposes, including measurements on acquired images.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0017522
Registration Date
October 01, 2015
Change Notification Approval Date
September 19, 2017
Retention Due Date
September 30, 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)
E8C disposable Biopsy Starter kit 4C-RS LOGIQ P9 R2.5 LOGIQ P7 R2.5 LP7-P9 R2 to R2.5 GI Upgrade E8C-RS - need China label 8C-RS 12L-RS E8C reusable Guide Attachment 9L-RS C1-5-RS L8-18i-RS ML6-15-RS BE9CS-RS LP7-P9 R1 to R2 PoC Upgrade LP7-P9 R1 to R2 GI Upgrade 12S-RS 6S-RS 3Sc-RS - need GEMS China label P8D LOGIQ P7 Standard LOGIQ P7 Tall LOGIQ P9 LOGIQ P9 with Articulating Monitor Arm LOGIQ P7 with High Cabinet L3-9i-RS LOGIQ P7 R2 LOGIQ P9 R2 Foot Switch Unit L4-12t-RS L6-12-RS E8CS-RS L12n-RS P6D L10-22-RS RAB2-6-RS RIC5-9A-RS
Model Identifier(s)
E8333JB H4000SR H40282LT H40292LB H40292LD H40402LN H40402LS H40402LY H40412LN H40442LL H40462LA H40462LF H40462LM H40482LN H42832LC H42832LE H44901AB H45021RP H45041DL H46312LZ H46432LJ H46432LL H46432LM H46432LR H46432LS H46442LK H46442LL H46442LM H46732LF H48062AB H48062AC H48062AF H48062AH H4830JG H48312AH H48681WR H48701EJ