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Fujifilm Sonosite ST Ultrasound System - HSA Registration DE0508590

Access comprehensive regulatory information for Fujifilm Sonosite ST 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 DE0508590 and owned by Fujifilm SonoSite, Inc. The device was registered on October 20, 2023.

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
DE0508590
Fujifilm Sonosite ST Ultrasound System
HSA Registration Number: DE0508590
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Product Description

The Sonosite ST 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. Specific clinical applications and exam types include: Abdominal Needle guidance Adult cephalic Ophthalmic Cardiac adult Pediatric Cardiac pediatric Peripheral vessel Fetal - OB/GYN Small organ (breast, thyroid, testicles, prostate) Musculoskeletal (conventional) Transrectal Musculoskeletal (superficial) Transvaginal

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508590
Registration Date
October 20, 2023
Change Notification Approval Date
October 21, 2024
Retention Due Date
October 19, 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
Model Information
Model Name(s)
NEEDLE GUIDE STARTER KIT, IC10- 3 SERIES Assembly PowerPark Dock Module Transducer, L12-3 Transducer, C10-3 Transducer, C5-1 Transducer, L15-4 Transducer, IC10-3 Transducer, L19-5 Transducer, P5-1 PowerPark Stand Module AC/DC Power Supply Sonosite Stand Battery NEEDLE GUIDE STARTER KIT, C5-1 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, C10-3 SERIES, INFINITI PLUS NEEDLE GUIDE BRACKET, C10-3 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L12-3 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L15-4 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L19-5 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L19-5 SERIES, ACCUSITE Small Basket (Kit #2) Sonosite ST Ultrasound System SONOSITE ST STAND HEAD SONOSITE ST STAND Large Basket (Kit A) Large baskets (Kit B) Small Basket (Kit#1)
Model Identifier(s)
P03883-06 P12834-40 P22916-20 P23117-20 P23119-21 P23120-20 P23121-22 P23972-22 P24087-22 P25003-15 P25255-02 P27003-21 P27060-01 P27062-01 P27063-01 P27064-01 P27066-01 P27068-01 P27070-01 P28950-01 P31200-21 P31203-20 P31204-20 P31787-01 P31790-01 P31960-01