Singapore HSA registration DE0502870
Edwards Lifesciences INSPIRIS RESILIA Aortic Valve
Singapore·CLASS D·Edwards Lifesciences LLC·Registered March 13, 2019Device 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 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.
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
About this record
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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