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FUJIFILM SonoSite Edge II Ultrasound System - HSA Registration DE0018708

Access comprehensive regulatory information for FUJIFILM SonoSite Edge II 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 DE0018708 and owned by Fujifilm SonoSite, Inc. The device was registered on November 07, 2016.

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
DE0018708
FUJIFILM SonoSite Edge II Ultrasound System
HSA Registration Number: DE0018708
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Product Description

The FUJIFILM SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Indications of Use: Ophthalmic, Fetal - OB/GYN, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0018708
Registration Date
November 07, 2016
Change Notification Approval Date
May 11, 2020
Retention Due Date
November 06, 2025
Product Owner
Short Name
Fujifilm SonoSite, Inc
Address
21919 30th Dr SE,, Bothell, WA, 98021-3904, 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)
ECG Cable and Leadwires C11x/8-5 MHz Transducer ICTx/8-5 MHz Transducer L25x/13-6 MHz Transducer HFL50x/15-6 MHz Transducer P10x/8-4 MHz Transducer Power Supply SiteLink Image Manager L38xi/10-5 MHz Transducer PowerPark Stand Module PowerPark Dock PowerPack Bar Code Scanner Kit Battery Edge Mini-Dock Edge Stand Triple Transducer Connect Wireless Kit L38xi/10-5 MHz Transducer, Armored TEExi/8-3 MHz Transducer ECG Slave Cable and Adapter Kit HFL38xi/13-6 MHz Transducer HFL38xi/13 - 6 MHZ Armored Transducer HSL25x/13-6 MHz Transducer SonoSite Edge II Ultrasound System Bite Hole Indication Meter Kit rP19x/5-1 MHz Transducer rC60xi/5-2 MHz Transducer SonoSite Patient Data Archival Software (PDAS) rP19x/5-1 MHz Transducer, Armored rC60xi/5-2 MHz Transducer, Armored TEExi/8-3 MHz Transducer (Service Exchange Unit) C35x/ 8-3 MHZ Transducer L25x/13-6 MHZ, Armored Transducer Wireless Module
Model Identifier(s)
P01592 P07678 P07690 P07691 P07693 P07696 P09823 P10117 P12742 P12822 P12834 P13122 P14166 P15051 P15078 P15800 P16535 P17726 P19626 P19825 P20262 P20311 P20377 P20679 P20680 P20870 P21015 P21070 P21178 P21556 P21636 P21677 P21981 P22950 P24559