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Singapore HSA registration DE0509502

Sonosite LX Ultrasound System and Accessories

Singapore flagSingapore·CLASS B·Fujifilm SonoSite, Inc·Registered July 08, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0509502
Registration Date
July 08, 2024
Retention Due Date
July 07, 2025
Product description
The Sonosite LX 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, Adult Cephalic, Neonatal Cephalic, Cardiac Adult, Cardiac Pediatric, Fetal - OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Peripheral vessel, Small Organ (breast, thyroid, testicles, prostate), Transesophageal (cardiac), Transrectal, Transvaginal, Needle Guidance
Product Owner
Name
Fujifilm SonoSite, Inc
Short Name
Fujifilm SonoSite, Inc
Address
21919 30th Dr. SE, Bothell, WA 98021-3904, UNITED STATES
Registrant
Name
Bluestone Corporation Pte Ltd
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Importer
Name
Bluestone Corporation Pte Ltd
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Model information
Model Name(s)
Assembly PowerPark Dock Module Kit, USB Bar Code Scanner, Jadak Transducer, L12-3 Transducer, C10-3 Transducer, C5-1 Transducer, L15-4 Transducer, IC10-3 Transducer, L19-5 Transducer, P5-1 Sonosite PowerPark Stand Module Sonosite LX Ultrasound System Cable, Leadwires, ECG Sonosite ECG Module External ECG Connector Cable and Adapter Transducer, T8-3 Transducer, P11-3 Sonosite ECG Module Leadwires Kit, Battery And Accessory, Sonosite LX T8-3 ULT-2020 Ultrasound Leakage Tester Kit Transducer, L13-6 Microphone
Model Identifier(s)
P12834 P14166 P22916 P23117 P23119 P23120 P23121 P23972 P24087 P25003 P28354 P28427 P29077 P29189 P29465 P29671 P30130 P30205 P30248 P30257 P31093
About this record

Access comprehensive regulatory information for Sonosite LX Ultrasound System and Accessories in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509502 and owned by Fujifilm SonoSite, Inc. The device was registered on July 08, 2024.

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