Singapore HSA registration DE0506311
Edwards KONECT RESILIA Aortic Valved Conduit
Singapore·CLASS D·Edwards Lifesciences LLC·Registered October 21, 2021Device 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 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.
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
About this record
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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