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Edwards Lifesciences INSPIRIS RESILIA Aortic Valve - HSA Registration DE0502870

Access comprehensive regulatory information for Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0502870 and owned by Edwards Lifesciences LLC. The device was registered on March 13, 2019.

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
DE0502870
Edwards Lifesciences INSPIRIS RESILIA Aortic Valve
HSA Registration Number: DE0502870
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Product Description

The INSPIRIS RESILIA aortic valve, Model 11500A, is intended for use as a heart valve replacement. The INSPIRIS RESILIA aortic valve, Model 11500A, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0502870
Registration Date
March 13, 2019
Change Notification Approval Date
April 04, 2025
Retention Due Date
March 12, 2026
Product Owner
Short Name
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, UNITED STATES
Registrant
Address
238B THOMSON ROAD, NOVENA SQUARE, #18-01/08, SINGAPORE 307685
Importer
Address
35 CHANGI NORTH CRESCENT, SINGAPORE 499641
Model Information
Model Name(s)
Edwards Lifesciences Universal Handle Edwards Lifesciences PERIMOUNT Magna Ease Sizer Edwards Lifesciences INSPIRIS RESILIA AORTIC VALVE Edwards Lifesciences PERIMOUNT Magna Ease Sizer Tray
Model Identifier(s)
1111 1133 11500A TRAY1133