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Fujifilm SonoSite Edge Ultrasound System - HSA Registration DE0014493

Access comprehensive regulatory information for Fujifilm SonoSite Edge 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 DE0014493 and owned by FUJIFILM Sonosite, Inc.. The device was registered on December 18, 2013.

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
DE0014493
Fujifilm SonoSite Edge Ultrasound System
HSA Registration Number: DE0014493
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Product Description

The Fujifilm SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Paediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Paediatric, Trans-esophageal (cardiac), Peripheral Vessel. Biopsy guidance Needle guidance

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0014493
Registration Date
December 18, 2013
Retention Due Date
December 17, 2025
Product Owner
Short Name
FUJIFILM Sonosite
Address
21919 30th Drive SE, Bothell, Washington, 98021, UNITED STATES
Registrant
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Importer
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model Information
Model Name(s)
Needle Guide Starter Kit, L38, HFL38 Series Needle Guide Starter Kit, C60 Series Needle Guide Starter Kit, C8 Series (reusable) Needle Guide Starter Kit, ICT Series D2x / 2 MHz Transducer TEEx / 8-3 MHz Transducer Needle Guide Starter Kit, P10 Series Needle Guide Starter Kit, C8 Series (disposable) C11x / 8-5 MHz Transducer C60x / 5-2 MHz Transducer HFL38x / 13-6 MHz Transducer ICTx / 8-5 MHz Transducer L25x / 13-6 MHz Transducer HFL50x / 15-6 MHz transducer P10x / 8-4 MHz Transducer P21x / 5-1 MHz Transducer SLAx / 13-6 MHz Transducer Needle Guide Starter Kit, P21 Series Color Doppler and Velocity color Continuous Wave Doppler Pulsed Wave Doppler Clips Storage TCD Imaging Credentialing Worksheets Advanced OB/GYN Calculations Standard Application Software Package, M-Turbo Bundle – PW / CW SonoCalc Embedded IMT 1.1 Needle Guide Starter Kit, HFL50 Series L38xi / 10-5 MHz Transducer DICOM Bundle (Print, Store, Worklist, MPPS, Storage Commit) DICOM Upgrade Needle Guide Starter Kit, L38xi Series, Multi-angle Needle Guide Starter Kit, 18 G, L25 Series Needle Guide Starter Kit, 21 G, L25 Series Needle Guide Starter Kit, 22 G, L25 Series MSK Worksheet ACO Technology SonoMBe EDGE Ultrasound System Battery - EDGE
Model Identifier(s)
P01300 P01882 P03372 P03883 P05165 P05183 P05187 P06388 P07678 P07680 P07682 P07690 P07691 P07693 P07696 P07698 P07699 P07873 P08293 P08294 P08295 P08298 P08302 P08304 P08525 P08592 P08965 P10115 P12051 P12742 P12819 P12823 P12868 P12920 P12922 P12924 P13269 P13292 P13930 P15000 P15051