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Bard Site~Rite 8 Ultrasound System - HSA Registration DE0018440

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 DE0018440 and owned by Bard Access Systems, Inc.. The device was registered on August 08, 2016.

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
DE0018440
Bard Site~Rite 8 Ultrasound System
HSA Registration Number: DE0018440
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Product Description

The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: Pediatric, Peripheral Vessel, Small Organ (breast, thyroid, parathyroid, testicles), Musculo-skeletal (conventional and superficial), Cardiac (adult and pediatric)

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0018440
Registration Date
August 08, 2016
Change Notification Approval Date
November 15, 2024
Retention Due Date
August 07, 2025
Product Owner
Short Name
Bard Access Systems, Inc.
Address
605 North 5600 West, Salt Lake City, Utah, 84116, UNITED STATES
Registrant
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Address
10 ANSON ROAD, INTERNATIONAL PLAZA, #33-07/08, SINGAPORE 079903 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model Information
Model Name(s)
Medical Equipment Rollstand Power Cord Site~Rite 8 Ultrasound System Portable Kit Site~Rite 8 Ultrasound System Kickstand Site~Rite 8 Ultrasound System Power Supply Site~Rite 8 Ultrasound System Probe Holder Site~Rite 8 Ultrasound System Sherlock 3CG Activation Key Site~Rite 8 Ultrasound System Roller Bag Site~Rite 8 Ultrasound System Keyboard Site~Rite 8 Ultrasound System
Model Identifier(s)
9770206 9770231 9770502 9770503 9770504 9770505 9770508 9770515 9770517 9770553