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GE Venue Fit Ultrasound System - HSA Registration DE0507957

Access comprehensive regulatory information for GE Venue Fit 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 DE0507957 and owned by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. The device was registered on March 30, 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
DE0507957
GE Venue Fit Ultrasound System
HSA Registration Number: DE0507957
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Product Description

The Venue Fit is a general-purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and 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
DE0507957
Registration Date
March 30, 2023
Retention Due Date
March 29, 2026
Product Owner
Short Name
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Address
9900 Innovation Drive, Wauwatosa, WI 53226, 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 M5Sc-RS L4-20t-RS Biopsy Starter Kit E8C-RS Disposable Biopsy Guide Protek - 24 Sterile endocavity needle guide kits w/covers Biopsy Starter Kit Biopsy Starter Kit Verza Guidance System Venue Fit ECG kit for IEC Ultra-Pro IIโ„ข In-Plane Ultrasound Needle Guide for M5Sc-RS Ultra-Pro IIโ„ข In-Plane Ultrasound Needle Guide for 3Sc-RS Biopsy Starter Kit Biopsy Starter Kit 6Tc-RS Venue Fit Venue Fit
Model Identifier(s)
2354973 47236956 47237175 47237516 5141337 5212630 5318734 5384874 5393197 5428942 5433596 5441887 5718483 5843289 742-416 E8385MJ H40432LC H40432LE H45201BLF H45224VFEGG H45561FC H46222LC H48392LL H48392LT KN100106 Venue Fit R4 Venue Fit R4W