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Medtronic Radiant™ Balloon-Expandable Covered Stent - HSA Registration DE0508898

Access comprehensive regulatory information for Medtronic Radiant™ Balloon-Expandable Covered Stent in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0508898 and owned by Medtronic, Inc. The device was registered on January 26, 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.

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CLASS D
DE0508898
Medtronic Radiant™ Balloon-Expandable Covered Stent
HSA Registration Number: DE0508898
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Product Description

The Radiant balloon-expandable covered stent system is intended to maintain perfusion to the renal arteries when used in combination with the Endurant II/IIs stent graft system. The devices are used together to repair juxtarenal abdominal aortic or aortoiliac aneurysms with a parallel graft technique in an endovascular approach. This is accomplished by providing an alternative conduit for blood flow within the patient’s vessel (aorta, iliac, and renal arteries) by excluding the aneurysm (target lesion).

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508898
Registration Date
January 26, 2024
Retention Due Date
January 25, 2026
Product Owner
Short Name
Medtronic, Inc
Address
710 Medtronic Parkway, Minneapolis, MN 55432, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
Radiant™ Balloon-Expandable Covered Stent Radiant™ Balloon-Expandable Covered Stent Radiant™ Balloon-Expandable Covered Stent Radiant™ Balloon-Expandable Covered Stent Radiant™ Balloon-Expandable Covered Stent Radiant™ Balloon-Expandable Covered Stent Radiant™ Balloon-Expandable Covered Stent Radiant™ Balloon-Expandable Covered Stent
Model Identifier(s)
RBXCS622120EE RBXCS632120EE RBXCS638120EE RBXCS659120EE RBXCS722120EE RBXCS732120EE RBXCS738120EE RBXCS759120EE