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Singapore HSA registration DE0509309

Bard Site~Rite® 8 Ultrasound System

Singapore flagSingapore·CLASS B·Bard Access Systems, Inc.·Registered May 23, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0509309
Registration Date
May 23, 2024
Retention Due Date
May 22, 2025
Product description
The SiteRite 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include Pediatric, Peripheral Vessel and Vascular Access, Small Organ (breast, thyroid, parathyroid, testicles), Musculo-skeletal (conventional and superficial), Cardiac (adult and pediatric). Cue Needle Tracking System and Pinpoint GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access.
Product Owner
Name
Bard Access Systems, Inc.
Short Name
Bard Access Systems, Inc.
Address
605 North 5600 West, Salt Lake City, UT 84116, Salt Lake City, Utah, UNITED STATES
Registrant
Name
BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Name
BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model information
Model Name(s)
SR8 Roller bag only. (No kickstand or probe holder) SR8 OUS Do It Yourself Battery Kit Radel 3CG+ Large Y Sensor Radel 3CG+ Small Y Sensor CE Marked SR8 Detachable 32mm probe CE Marked SR8 20mm Detachable Cue probe SR8 Cue Needle Activator SR8 Cue Needle Activator Mounting arm 6 ft (1.83 meter) Power Cord Kit. UK, EU, Brazil, and Australia power cords SR8 Cue Enabled Ultrasound system ROW Blue Tooth Remote and USB Hub for Surface Pro 3CG / Netbook remote operation Printer mount for MER rollstands Surface Pro 3CG+  Rollstand Mounting Hardware/Enclosure Sony Thermal Printer
Model Identifier(s)
1055776657 9770270 9770362 9770363 9770601 9770603 9770604 9770605 9770655 9770660 AMP09US BAR000206 BAR000280 UPX898MD
About this record

Access comprehensive regulatory information for Bard Site~Rite® 8 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 DE0509309 and owned by Bard Access Systems, Inc.. The device was registered on May 23, 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