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GE Versana Essential Ultrasound System - HSA Registration DE0501525

Access comprehensive regulatory information for GE Versana Essential 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 DE0501525 and owned by GE Medical Systems (China) Co., Ltd.. The device was registered on April 13, 2018.

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
DE0501525
GE Versana Essential Ultrasound System
HSA Registration Number: DE0501525
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Product Description

The Versana Essential is intended for use by a qualified physician for ultrasound evaluation. The Versana Essential are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Transvaginal, Urological and Cardiac, Transrectal, imaging guidance of interventional procedure and biopsy.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0501525
Registration Date
April 13, 2018
Retention Due Date
April 12, 2026
Product Owner
Short Name
GE Medical Systems
Address
No. 19, Changjiang Road, Wuxi, Jiangsu, 214028, CHINA
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)
Needle Guide (E8C-RS) Biopsy Starter Kit (4C-RS) 4C-RS E8C-RS E8C Reusable Guide Attachment Biopsy Starter Kit (L6-12-RS) 3Sc-RS Biopsy Starter Kit (3Sc-RS) L6-12-RS Versana Essential VS Versana Essential VA Versana Essential VS Versana Essential VA Versana Essential VA L5-11-RS C2-5-RS Biopsy Starter Kit (L6-12-RS)
Model Identifier(s)
E8385MJ E8385NA H4000SR H40402LN H40412LN H40432LC H45041DL H46222LC H48062AC H48102BA H48102BB H48102BC H48102BD H48102BE H48102BJ H48102BK H48392LT