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Applicant profile

Edwards Lifesciences LLC

Edwards Lifesciences
Hong Kong MDACSUnited States16 registered devicesSep 23, 2015 – Jul 16, 2024
VerifiedMDD (Medical Device Division) · MDACS registry
16
Total devices
3
Risk classes
2015
First registration
2024
Most recent
Applicant overview
Applicant (EN)
Edwards Lifesciences LLC
Applicant (ZH)
Edwards Lifesciences
Country
United States
美国
Address
One Edwards Way, Irvine, CA 92614, USA
爱德华兹路一号,尔湾,CA 92614,美国
Timeline
First registration
Sep 23, 2015
Most recent
Jul 16, 2024
Regulatory footprint
Search Edwards Lifesciences LLC across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Risk class breakdown
II3
III3
IV10
Recent MDACS registrations
Latest 15 devices linked to this applicant
Prostheses, Cardiac Valve, Biological
假体, 心脏瓣膜, 生物
Jul 16, 2024
Risk class
IV
Authorised rep
Edwards Lifesciences Hong Kong Limited
Prostheses, Cardiac Valve, Biological
假体, 心脏瓣膜, 生物
Jun 06, 2024
Risk class
IV
Authorised rep
Edwards Lifesciences Hong Kong Limited
Prostheses, Cardiac Valve, Biological
假体, 心脏瓣膜, 生物
Dec 06, 2023
Risk class
IV
Authorised rep
Edwards Lifesciences Hong Kong Limited
Prostheses, Cardiac Valve, Biological
假体, 心脏瓣膜, 生物
Aug 29, 2023
Risk class
IV
Authorised rep
Edwards Lifesciences Hong Kong Limited
Transducers, Pressure, Disposable
传感器, 压力, 一次性
Jul 12, 2023
Risk class
II
Authorised rep
Edwards Lifesciences Hong Kong Limited
Annuloplasty Ring/Band Implants
环成形术环/带状植入物
May 09, 2023
Risk class
IV
Authorised rep
Edwards Lifesciences Hong Kong Limited
Annuloplasty Ring/Band Implants
环成形术环/带状植入物
Mar 03, 2023
Risk class
IV
Authorised rep
Edwards Lifesciences Hong Kong Limited
Prostheses, Cardiac Valve, Biological
假体, 心脏瓣膜, 生物
Mar 03, 2023
Risk class
IV
Authorised rep
Edwards Lifesciences Hong Kong Limited
Annuloplasty Ring/Band Implants
环成形术环/带状植入物
Nov 21, 2022
Risk class
IV
Authorised rep
Edwards Lifesciences Hong Kong Limited
Monitors, Physiologic, Cardiac Output, Bedside
监护仪, 生理, 心输出量, 床边
Nov 21, 2022
Risk class
III
Authorised rep
Edwards Lifesciences Hong Kong Limited
Monitoring Systems, Physiologic
生理监测系统
Nov 04, 2022
Risk class
III
Authorised rep
Edwards Lifesciences Hong Kong Limited
Transducers, Pressure
压力传感器
Nov 04, 2022
Risk class
II
Authorised rep
Edwards Lifesciences Hong Kong Limited
Monitors, Physiologic, Cardiac Output, Bedside
监护仪, 生理, 心输出量, 床边
Nov 04, 2022
Risk class
III
Authorised rep
Edwards Lifesciences Hong Kong Limited
Cannulae, Femoral
插管,股骨
Nov 04, 2022
Risk class
II
Authorised rep
Edwards Lifesciences Hong Kong Limited
Prostheses, Cardiac Valve, Biological
假体, 心脏瓣膜, 生物
Nov 09, 2017
Risk class
IV
Authorised rep
DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
View all 16 devices →
About this profile

Edwards Lifesciences LLC is associated with 16 medical devices registered under the Hong Kong Medical Device Administrative Control System (MDACS). Explore bilingual product names, risk classes, authorised representatives, and life-cycle milestones.