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Singapore HSA registration DE0018305

Edwards Lifesciences Carpentier-Edwards Physio Tricuspid Annuloplasty Ring

Singapore flagSingapore·CLASS D·Edwards Lifesciences LLC·Registered June 30, 2016
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0018305
Registration Date
June 30, 2016
Change Notification Approval Date
July 04, 2024
Retention Due Date
June 29, 2025
Product description
The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid insufficiency, to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
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 Model 1150 (reusable, non-sterile) Handle Model 1151 (reusable, non-sterile) Physio Tricuspid Ring Sizer Physio Tricuspid Ring Sizer Physio Tricuspid Ring Sizer Physio Tricuspid Ring Sizer Physio Tricuspid Ring Sizer Physio Tricuspid Ring Sizer Physio Tricuspid Ring Sizer Carpentier-Edwards Physio Tricuspid Ring Carpentier-Edwards Physio Tricuspid Ring Carpentier-Edwards Physio Tricuspid Ring Carpentier-Edwards Physio Tricuspid Ring Carpentier-Edwards Physio Tricuspid Ring Carpentier-Edwards Physio Tricuspid Ring Carpentier-Edwards Physio Tricuspid Ring Sizer/Handle Tray
Model Identifier(s)
1150 1151 1262T24 1262T26 1262T28 1262T30 1262T32 1262T34 1262T36 6200T24 6200T26 6200T28 6200T30 6200T32 6200T34 6200T36 TRAY1262
About this record

Access comprehensive regulatory information for Edwards Lifesciences Carpentier-Edwards Physio Tricuspid 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 DE0018305 and owned by Edwards Lifesciences LLC. The device was registered on June 30, 2016.

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