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Singapore HSA registration DE0507272

Edwards MITRIS RESILIA Mitral Valve

Singapore flagSingapore·CLASS D·Edwards Lifesciences LLC·Registered September 19, 2022
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0507272
Registration Date
September 19, 2022
Change Notification Approval Date
March 04, 2025
Retention Due Date
September 18, 2025
Product description
The MITRIS RESILIA mitral valve, model 11400M, is intended for use as a heart valve replacement. The MITRIS RESILIA mitral valve, model 11400M, is indicated for the replacement of native or prosthetic mitral heart valves.
Product Owner
Name
Edwards Lifesciences LLC
Short Name
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, UNITED STATES
Registrant
Name
EDWARDS LIFESCIENCES (ASIA) PTE. LTD.
Address
238B THOMSON ROAD, NOVENA SQUARE, #18-01/08, SINGAPORE 307685
Importer
Name
EDWARDS LIFESCIENCES (SINGAPORE) PTE. LTD.
Address
35 CHANGI NORTH CRESCENT, SINGAPORE 499641
Model information
Model Name(s)
Edwards MITRIS RESILIA Mitral Valve Edwards MITRIS RESILIA Mitral Valve Edwards MITRIS RESILIA Mitral Valve Edwards MITRIS RESILIA Mitral Valve Edwards MITRIS RESILIA Mitral Valve Handle Model 1173B Mitral Barrel Sizer Model 1173B Mitral Barrel Sizer Model 1173B Mitral Barrel Sizer Model 1173B Mitral Barrel Sizer Model 1173B Mitral Barrel Sizer Model 1173R Mitral Replica Sizer Model 1173R Mitral Replica Sizer Model 1173R Mitral Replica Sizer Model 1173R Mitral Replica Sizer Model 1173R Mitral Replica Sizer Mitral Sizer/Handle Tray
Model Identifier(s)
11400M(25) 11400M(27) 11400M(29) 11400M(31) 11400M(33) 1140M 1173B(25) 1173B(27) 1173B(29) 1173B(31) 1173B(33) 1173R(25) 1173R(27) 1173R(29) 1173R(31) 1173R(33) SET1173
About this record

Access comprehensive regulatory information for Edwards MITRIS RESILIA Mitral 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 DE0507272 and owned by Edwards Lifesciences LLC. The device was registered on September 19, 2022.

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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