Singapore HSA registration DE0014496
Fujifilm SonoSite NanoMaxx Ultrasound System
Singapore·CLASS B·FUJIFILM Sonosite, Inc.·Registered December 18, 2013Device 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 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
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B