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Edwards KONECT RESILIA Aortic Valved Conduit - HSA Registration DE0506311

Access comprehensive regulatory information for Edwards KONECT RESILIA Aortic Valved Conduit in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506311 and owned by Edwards Lifesciences LLC. The device was registered on October 21, 2021.

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
DE0506311
Edwards KONECT RESILIA Aortic Valved Conduit
HSA Registration Number: DE0506311
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Product Description

The KONECT RESILIA AVC, Model 11060A, is intended for use as a replacement for the aortic heart valve and the ascending aorta. The KONECT RESILIA AVC, Model 11060A, is indicated for patients who require replacement of their native or prosthetic aortic valve and the associated repair or replacement of a damaged or diseased ascending aorta.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0506311
Registration Date
October 21, 2021
Change Notification Approval Date
April 04, 2025
Retention Due Date
October 20, 2025
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 KONECT RESILIA Aortic Valved Conduit Sizer Sizer Tray
Model Identifier(s)
11060A 1190 TRAY1190