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GE Vivid E Series Diagnostic Ultrasound System - HSA Registration DE0017658

Access comprehensive regulatory information for GE Vivid E Series Diagnostic 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 DE0017658 and owned by GE Vingmed Ultrasound AS. The device was registered on November 19, 2015.

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
DE0017658
GE Vivid E Series Diagnostic Ultrasound System
HSA Registration Number: DE0017658
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Product Description

Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0017658
Registration Date
November 19, 2015
Change Notification Approval Date
January 24, 2018
Retention Due Date
November 18, 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)
4V-D 8C 11L-D iC5-9-D 9L-D L8-18i-D C2-9-D C1-6-D C3-10-D 4Vc-D M5Sc-D 10T-D 6S-D 12S-D 9T 9T-RS TEE PROBE ADAPTER FOR 6T-RS/9T-RS TEE Cleaning and Storing system 6Tc 6Tc-RS 6VT-D Vivid E95 Vivid E80 RV Volume (TomTec) Vivid E90 MV Assessment (Tomtec) Vivid E95 Vivid E90 Vivid E80 Vivid E v201 to v202 UPG P2D P6D
Model Identifier(s)
H4001BT H40412LJ H40432LN H40442LK H40442LM H40452LL H40462LN H40472LT H40482LB H40482LS H44901AE H44901AH H45021RR H45021RT H45521DY H45531YM H45541PX H45551NK H45551ZD H45551ZE H45581BJ H45581DA H45581DC H45581GH H45581LB H45581LT H45591AA H45591AB H45591AC H45591AL H4830JE H4830JG