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Fujifilm SonoSite NanoMaxx Ultrasound System - HSA Registration DE0014496

Access comprehensive regulatory information for Fujifilm SonoSite NanoMaxx 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 DE0014496 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
DE0014496
Fujifilm SonoSite NanoMaxx Ultrasound System
HSA Registration Number: DE0014496
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Product Description

The SonoSite NanoMaxx 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: Fetal/OB; Abdominal; Paediatric; Small Organ (breast, thyroid, testicles, prostate); Trans-rectal; Trans-vaginal Peripheral Vessel; Intraoperative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Paediatric. 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
DE0014496
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)
C11n / 8-5 MHz Transducer C60n / 5-2 MHz Transducer ICTn / 8-5 MHz Transducer L25n / 13-6 MHz Transducer P21n / 5-1 MHz Transducer NanoMaxx Ultrasound System SonoCalc Embedded IMT L38n / 10-5 MHz Transducer Battery – NanoMaxx Needle Guide Starter Kit, 18 G, L25 Series Needle Guide Starter Kit, 21 G, L25 Series Needle Guide Starter Kit, 22 G, L25 Series DICOM Wireless bundle
Model Identifier(s)
P07678 P07680 P07690 P07691 P07698 P11111 P12673 P12742 P12889 P12920 P12922 P12924 P14122