Pure Global

GE Venue Ultrasound System - HSA Registration DE0510439

Access comprehensive regulatory information for GE Venue 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 DE0510439 and owned by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. The device was registered on March 07, 2025.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0510439
GE Venue Ultrasound System
HSA Registration Number: DE0510439
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

For use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education/training. Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: abdominal (GYN&Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional&superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0510439
Registration Date
March 07, 2025
Retention Due Date
March 06, 2026
Product Owner
Short Name
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Address
3200 N Grandview Blvd, Waukesha, WI 53188, UNITED STATES
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 ML6-15-RS L4-12t-RS L10-22-RS L12n-RS M5Sc-RS C2-9-RS L4-20t-RS Needle Guide Biopsy Starter Kit Biopsy Starter Kit ECG Kit W/ IEC Cable Verza Guidance System Biopsy Starter Kit Biopsy Starter kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit 6Tc-RS Venue Venue Venue
Model Identifier(s)
2354973 47236956 47237175 47237516 5141337 5212630 5318734 5384874 5393197 5428942 5433596 5441887 5505759 5718483 5761811 5843289 E8385MJ H40432LC H40432LE H45124VEEGG H45201BLF H45281BL H45561FC H46222LC H48392LL H48392LT KN100106 Venue R5 Venue R5 UPG Venue R5W