Pure Global

GE Vscan with Dual Probe Ultrasound System - HSA Registration DE0016375

Access comprehensive regulatory information for GE Vscan with Dual Probe 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 DE0016375 and owned by GE Vingmed Ultrasound AS. The device was registered on October 03, 2014.

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
DE0016375
GE Vscan with Dual Probe Ultrasound System
HSA Registration Number: DE0016375
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Vscan with Dual Probe is general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Peripheral Vascular Imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, thoracentesis, amniocentesis); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints; and Pediatrics.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0016375
Registration Date
October 03, 2014
Change Notification Approval Date
February 03, 2015
Retention Due Date
October 02, 2025
Product Owner
Short Name
GE Vingmed Ultrasound AS
Address
Strandpromenaden 45, N-3191 Horten, NORWAY
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)
Vscan with Dual Probe Vscan with DualProbe Rechargable Smart Battery Pack Vscan Battery Charger AC adapter micro SD Memory card USB cable CD with Vscan gateway Vscan with Dual Probe Docking Station Vscan with Dual Probe Soft case Vscan with Dual Probe Carrying Case Vscan with DualProbe Docking Station
Model Identifier(s)
GM000270 GM000310 GM200011 GM200039 GM200046 GM200047 GM200049 GM200187 GM200275 GM200277 GM200283 GM200359