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Medtronic Euphora™ Rapid Exchange Balloon Dilatation Catheter - HSA Registration DE0017664

Access comprehensive regulatory information for Medtronic Euphora™ Rapid Exchange Balloon Dilatation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0017664 and owned by Medtronic, Inc.. The device was registered on November 20, 2015.

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
DE0017664
Medtronic Euphora™ Rapid Exchange Balloon Dilatation Catheter
HSA Registration Number: DE0017664
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Product Description

The balloon catheter is indicated for use in coronary artery or bypass grafts to perform the following functions: • The balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. • The balloon catheter (balloon models that are 2.00 mm to 4.00 mm in diameter) is also indicated for post-delivery expansion of balloon-expandable stents.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0017664
Registration Date
November 20, 2015
Change Notification Approval Date
March 28, 2024
Retention Due Date
November 19, 2025
Product Owner
Short Name
Medtronic
Address
710 Medtronic Parkway NE, MN, 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)
RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter RX Euphora Rapid Exchange Balloon Dilatation Catheter
Model Identifier(s)
EUP1506X EUP1510X EUP1512X EUP1515X EUP1520X EUP2006X EUP2010X EUP2012X EUP2015X EUP2020X EUP2025X EUP2030X EUP22506X EUP22510X EUP22512X EUP22515X EUP22520X EUP22525X EUP2506X EUP2510X EUP2512X EUP2515X EUP2520X EUP2525X EUP2530X EUP27506X EUP27510X EUP27512X EUP27515X EUP27520X EUP27525X EUP3006X EUP3010X EUP3012X EUP3015X EUP3020X EUP3025X EUP3030X EUP32506X EUP32510X EUP32512X EUP32515X EUP32520X EUP32525X EUP3506X EUP3510X EUP3512X EUP3515X EUP3520X EUP3525X EUP3530X EUP37506X EUP37510X EUP37512X EUP37515X EUP37520X EUP37525X EUP4006X EUP4010X EUP4012X EUP4015X EUP4020X EUP4025X EUP4030X