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GE LOGIQ P8 / P9 / P10 Ultrasound System - HSA Registration DE0505724

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 DE0505724 and owned by GE Ultrasound Korea Ltd. The device was registered on April 28, 2021.

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
DE0505724
GE LOGIQ P8 / P9 / P10 Ultrasound System
HSA Registration Number: DE0505724
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Product Description

The LOGIQ P8/P9/P10 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, vascular) •Transesophageal 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
DE0505724
Registration Date
April 28, 2021
Retention Due Date
April 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 Sterile Disposable Endocavity Needle Guide Kits 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 C1-6-D C3-10-D Biopsy Starter Kit Biopsy Starter Kit BE9CS-RS Needle Guide Needle Guide 12S-RS M5Sc-RS L3-12-RS 6S-RS 3Sc-RS 6Tc-RS Biopsy Starter kit Biopsy Starter Kit P8D 10C-D C2-7-D L3-9i-RS L4-12t-RS L6-12-RS E8Cs-RS Biopsy Starter Kit P2D P6D L10-22-RS 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 LOGIQ P10 LOGIQ P10 LOGIQ P8 LOGIQ P9
Model Identifier(s)
E8333JB E8385MJ E8387M H40402LN H40402LS H40402LY H40432LC H40432LE H40432LJ H40442LL H40462LA H40462LF H40462LM H40472LT H40482LB H40482LK H40482LL H40482LN H42742LH H42742LJ H44901AB H44901AG H44901AP H45021RP H45041DL H45551ZE H45561FC H46222LC H46312LZ H46342LA H46422LM H46442LK H48062AB H48062AC H48062AF H48302AA H4830JE H4830JG H48312AH H48392LL H48392LT H48681GF H48681ML H48681WR H48691PJ H48691YW H48701EJ H4906BK H4913BB LOGIQ P10 R4 LOGIQ P10 R4 HD LOGIQ P8 R4 LOGIQ P9 R4