EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd

FDA Device Registration & Listing · Changi South East, SG · Registration 3007063218

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007063218
FEI Number
3007063218
Entity Name
EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd
City/State/Country
Changi South East, SG
Establishment Address
35 Changi North Crescent, Changi South East 499641, SG
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Edwards Lifesciences LLC (Owner Number: 9040666)
Owner / Operator Contact Address
One Edwards Way, Irvine, CA 92614, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P140031

All Registered Proprietary Names

PASCAL Precision Transcatheter Valve Repair System INSPIRIS RESILIA Aortic Valve Edwards Pericardial Aortic Bioprosthesis KONECT RESILIA Aortic Valved Conduit MITRIS RESILIA Mitral Valve TRIFORMIS RESILIA Tricuspid Valve EDWARDS INTUITY Elite Valve System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Crimper Edwards Commander Delivery System Edwards SAPIEN 3 Transcather Pulmonary Valve System with Alterra Adaptive Prestent Edwards SAPIEN 3 Pulmonic Delivery System Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System Edwards EVOQUE Loading System and Trimmer Edwards EVOQUE EVOQUE tricuspid delivery system, dilator kit, and loading system Edwards EVOQUE valve EVOQUE Qualcrimp crimping accessory Edwards Crimper Edwards Expandable Introducer Sheath Set Edwards SAPIEN XT Transcatheter Heart Valve Ascendra+ System NovaFlex + Delivery System Crimp Stopper NovaFlex+ System Ascendra+ Delivery System Ascendra + Introducer Sheath Set Edwards Dilator Kit Carpentier-Edwards Perimount Bioprosthesis Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System Edwards Crimper Edwards Certitude Introducer Sheath Edwards Certitude Delivery System Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Introducer Sheath Set Edwards eSheath Introducer Set- 914ES eSheath- 914ES Edwards eSheath Introducer Set- 916ES eSheath- 916ES Edwards COMMANDER Delivery System Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NKM Mitral Valve Repair Devices Unknown Class 3 N/A 2022-09-15
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2017-07-11
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2016-08-17
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2020-09-10
NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown Class 3 N/A 2024-02-02
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2014-06-18
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2014-06-18
DYE Replacement Heart-Valve Cardiovascular Class 3 870.3925 2008-01-17
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2015-06-22
NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown Class 3 N/A 2015-06-22

Official Correspondent

Denny Kouri

US Agent Details

Denny Kouri Kouri Business: EDWARDS LIFESCIENCES LLC Email: Dennett_Kouri@edwards.com Phone: (949) 2506827

Related Public Records

Same Entity

Edwards Lifesciences LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015179394 Edwards Lifesciences LTD Shannon Clare, IE
3017298588 Edwards Lifesciences Ireland Limited Limerick Munster, IE
3015287573 Edwards Lifesciences Guadalupe Cartago, CR
3008500478 Edwards Lifesciences LLC Draper, UT, US
2015691 EDWARDS LIFESCIENCES LLC IRVINE, CA, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0491-2025 Abbott Medical 3
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Z-0492-2025 Abbott Medical 3
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Z-0493-2025 Abbott Medical 3
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Z-0494-2025 Abbott Medical 3
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Z-0495-2025 Abbott Medical 3
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

Similar Registrations

Registration Number Establishment Name Location
2011171 Sterigenics US LLC Los Angeles, CA, US
3002807314 Synergy Health Ireland Ltd Tullamore Offaly, IE
3015807001 CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.) Sunrise, FL, US
2015691 EDWARDS LIFESCIENCES LLC IRVINE, CA, US
2939561 ABBOTT VASCULAR SANTA CLARA, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007063218. Last updated year: 2026. Please use registration number 3007063218 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.