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Singapore HSA registration DE0505808

Edwards Lifesciences Physio Flex Annuloplasty Ring

Singapore flagSingapore·CLASS D·Edwards Lifesciences LLC·Registered May 20, 2021
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0505808
Registration Date
May 20, 2021
Change Notification Approval Date
July 04, 2024
Retention Due Date
May 19, 2025
Product description
The Physio Flex annuloplasty ring, model 5300, is intended to repair a malfunctioning mitral heart valve. The Physio Flex annuloplasty ring, model 5300, is indicated for patients who require the correction of mitral valve insufficiency, or mixed mitral insufficiency valve disease, where treatment does not necessitate replacement of the natural mitral valve.
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)
Handle Handle Sizer Sizer Sizer Sizer Sizer Sizer Sizer Sizer Sizer Physio Flex Annuloplasty Ring Physio Flex Annuloplasty Ring Physio Flex Annuloplasty Ring Physio Flex Annuloplasty Ring Physio Flex Annuloplasty Ring Physio Flex Annuloplasty Ring Physio Flex Annuloplasty Ring Physio Flex Annuloplasty Ring Physio Flex Annuloplasty Ring Sizer/Handle Tray - Mitral
Model Identifier(s)
1150 1151 1252M24 1252M26 1252M28 1252M30 1252M32 1252M34 1252M36 1252M38 1252M40 5300M24 5300M26 5300M28 5300M30 5300M32 5300M34 5300M36 5300M38 5300M40 TRAY1252
About this record

Access comprehensive regulatory information for Edwards Lifesciences Physio Flex Annuloplasty Ring in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505808 and owned by Edwards Lifesciences LLC. The device was registered on May 20, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D