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Bracco Diagnostics CardioGen-82 Infusion System - HSA Registration DE0510451

Access comprehensive regulatory information for Bracco Diagnostics CardioGen-82 Infusion System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510451 and owned by Bracco Diagnostics Inc.. The device was registered on March 12, 2025.

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 C
DE0510451
Bracco Diagnostics CardioGen-82 Infusion System
HSA Registration Number: DE0510451
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Product Description

The CardioGen-82® Infusion System is intended to be used with the Cardiogen-82® Generator to deliver the radiopharmaceutical eluate rubidium (Rb 82) chloride injection to a patient in a controlled manner. Users of the CardioGen-82® Infusion System must be Nuclear Medicine Technologists. The CardioGen-82® Infusion System is intended to be used in a healthcare facility.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0510451
Registration Date
March 12, 2025
Retention Due Date
March 11, 2026
Product Owner
Short Name
Bracco Diagnostics Inc.
Address
510 Carnegie Center, Princeton, New Jersey 08540, UNITED STATES
Registrant
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model Information
Model Name(s)
Patient Administration Set, For Use With CardioGen-82® Infusion System Vented Cap for Waste Bottle, For Use With CardioGen-82® Infusion System Waste Bottle, For Use With CardioGen-82® Infusion System Elution Test Vial Shield, For Use With CardioGen-82® Infusion System CardioGen-82 Infusion System Model 1701 Accessory Package, For Use with CardioGen-82® Infusion System Models 1700 & 1701 Elution Test Vial, For Use with CardioGen-82® Infusion System
Model Identifier(s)
1506 1511 1520 1550 1701 1710 1730