Applicant profile

Edwards Lifesciences LLC

Edwards Lifesciences

Hong Kong MDACS·United States·16 registered devices·Sep 23, 2015 – Jul 16, 2024

Total devices

Risk classes

2015

First registration

2024

Most recent

Applicant overview

Bilingual manufacturer details sourced from Hong Kong MDACS

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

Risk class breakdown

III

Recent MDACS registrations

Latest 15 devices linked to this applicant

Device	Risk class	Authorised rep	Registered
Prostheses, Cardiac Valve, Biological 假体, 心脏瓣膜, 生物	IV	Edwards Lifesciences Hong Kong Limited	Jul 16, 2024
Prostheses, Cardiac Valve, Biological 假体, 心脏瓣膜, 生物	IV	Edwards Lifesciences Hong Kong Limited	Jun 06, 2024
Prostheses, Cardiac Valve, Biological 假体, 心脏瓣膜, 生物	IV	Edwards Lifesciences Hong Kong Limited	Dec 06, 2023
Prostheses, Cardiac Valve, Biological 假体, 心脏瓣膜, 生物	IV	Edwards Lifesciences Hong Kong Limited	Aug 29, 2023
Transducers, Pressure, Disposable 传感器, 压力, 一次性	II	Edwards Lifesciences Hong Kong Limited	Jul 12, 2023
Annuloplasty Ring/Band Implants 环成形术环/带状植入物	IV	Edwards Lifesciences Hong Kong Limited	May 09, 2023
Annuloplasty Ring/Band Implants 环成形术环/带状植入物	IV	Edwards Lifesciences Hong Kong Limited	Mar 03, 2023
Prostheses, Cardiac Valve, Biological 假体, 心脏瓣膜, 生物	IV	Edwards Lifesciences Hong Kong Limited	Mar 03, 2023
Annuloplasty Ring/Band Implants 环成形术环/带状植入物	IV	Edwards Lifesciences Hong Kong Limited	Nov 21, 2022
Monitors, Physiologic, Cardiac Output, Bedside 监护仪, 生理, 心输出量, 床边	III	Edwards Lifesciences Hong Kong Limited	Nov 21, 2022
Monitoring Systems, Physiologic 生理监测系统	III	Edwards Lifesciences Hong Kong Limited	Nov 04, 2022
Transducers, Pressure 压力传感器	II	Edwards Lifesciences Hong Kong Limited	Nov 04, 2022
Monitors, Physiologic, Cardiac Output, Bedside 监护仪, 生理, 心输出量, 床边	III	Edwards Lifesciences Hong Kong Limited	Nov 04, 2022
Cannulae, Femoral 插管,股骨	II	Edwards Lifesciences Hong Kong Limited	Nov 04, 2022
Prostheses, Cardiac Valve, Biological 假体, 心脏瓣膜, 生物	IV	DCH Auriga (Hong Kong) Limited 奥利佳(香港)有限公司	Nov 09, 2017

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.