Pure Global

GE Vivid S60/ S70 Ultrasound System - HSA Registration DE0017460

Access comprehensive regulatory information for GE Vivid S60/ S70 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 DE0017460 and owned by GE Medical Systems Israel. The device was registered on September 09, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0017460
GE Vivid S60/ S70 Ultrasound System
HSA Registration Number: DE0017460
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Vivid S60/S70 ultrasound system 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 the following clinical applications: • Cardiac (Adult & Pediatrics) • Pediatrics • Fetal/Obstetrics • Abdominal (Including Renal & Gyn) • Peripheral Vascular • Transesophageal • Neonatal cephalic • Adult cephalic • Musculo-skeletal Conventional • Small organ (including breast, thyroid, testes) • Urology (Including prostate)

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0017460
Registration Date
September 09, 2015
Change Notification Approval Date
March 24, 2016
Retention Due Date
September 08, 2025
Product Owner
Short Name
GE Medical Systems
Address
4 Etgar Street, Tirat Carmel 39120, ISRAEL
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)
9L-D A/N kbd field Installed C1-6-D M5Sc-D 6S-D 12S-D 3Sc-RS 3Sc-RS Biopsy Kit VS60 VS70 Smart Standby - Battery Smart Stress Auto EF AFI Advanced Qscan imaging QA IMT TEE probe Interface LVO Contrast Scan Assist Pro Advanced 4D DICOM Network Connectivity MPEGVue, eVue Embedded DICOM viewer on DVDs RS Locker 4D Rodent ECG cable, adult, IEC ECG lead set, adult, IEC A/N kbd factory Installed Biteguard Clip-On Bite Guard Adult Adult TEE Scanhead Protection Cover PediatricBiteguard IM-50 BiteGuard Disposable Biteblock 9T-RS Scanhead Protection Covers Pediatric TEE Cleaning and Storing system 6Tc-RS Multi-Link ECG Cable GE Healthcare ECG Electrodes Adapter, ECG 3-lead 6VT-D 4D MV quant. (TomTec) Tripedal footswitch P2D 9L-D Biopsy Kit C1-6-D Biopsy kit
Model Identifier(s)
H40442LM H40451AA H40472LT H44901AE H45021RR H45021RT H45041DL H45041FX H45041SU H45041SW H45051AB H45051AD H45051AE H45051AF H45051AH H45051AI H45051AK H45051AL H45051AM H45051AN H45051AO H45051AP H45051AQ H45051AS H45051CT H45051CY H45051TV H45051UA H45051UB H45051UC H45511EE H45521CB H45521CK H45521JG H45521JH H45531YM H45541RN H45551NK H45551ZE H45571RE H45571RK H45571RL H45581BJ H45581LT H46732LF H4830JE H4906BK H4913BB