Pure Global

Fujifilm SonoSite MicroMaxx Ultrasound System - HSA Registration DE0014494

Access comprehensive regulatory information for Fujifilm SonoSite MicroMaxx 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 DE0014494 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0014494
Fujifilm SonoSite MicroMaxx Ultrasound System
HSA Registration Number: DE0014494
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The SonoSite MicroMaxx Series 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.), Laparoscopic Paediatric, Small Organ (breast, thyroid, testicle, ), 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
DE0014494
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 ICT / 8-5 MHz transducer Needle Guide Starter Kit, P17 Series D2 / 2 MHz transducer SLA / 13-6 MHz transducer SLT / 10-5 MHz transducer P10 / 8-4 MHz transducer TEE / 8-3 MHz transducer Needle Guide Starter Kit, P10 Series Color Doppler and Velocity color Continuous Wave Doppler Pulsed Wave Doppler Bundle - Pulsed Wave Doppler/Tissue Harmonic Imaging / Continuous Wave Doppler Bundle – Pulsed Wave Doppler/Tissue Harmonic Imaging SonoCalc Embedded IMT 1.1 Clips Storage OB/GYN Calculations L38e / 10-5 MHz transducer P17 / 5-1 MHz transducer SonoRES TCD Imaging Needle Guide Starter Kit, C8 Series (disposable) Bundle – TCD/PW/VC C11e / 8-5 MHz transducer Battery – MicroMaxx Credentialing Worksheets HFL38 / 13-6 MHz transducer C60e / 5-2 MHz transducer L25e / 13-6 MHz Transducer C8 / 8-5 MHz array transducer MicroMaxx Ultrasound System DICOM/ (Print, Store, Worklist) DICOM Upgrade Needle Guide Starter Kit, 18 G, L25 Series Needle Guide Starter Kit, 21 G, L25 Series Needle Guide Starter Kit, 22 G, L25 Series
Model Identifier(s)
P01300 P01882 P03372 P03883 P04538 P04999 P05165 P05174 P05180 P05182 P05183 P05187 P05297 P05298 P05299 P05301 P05306 P05337 P05338 P05347 P05482 P06073 P06112 P06306 P06388 P06719 P07161 P07168 P07631 P07632 P07633 P07634 P08010 P08840 P12821 P12825 P12920 P12922 P12924