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16 Devices

Edwards Lifesciences LLC - Applicant Profile

Edwards Lifesciences

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.

3 Risk Classes
Since 2015
Latest 2024
Applicant Overview
Bilingual manufacturer details sourced from Hong Kong MDACS.
Applicant (EN)
Edwards Lifesciences LLC
Country
United States
็พŽๅ›ฝ
Applicant (ZH)
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, USA
็ˆฑๅพทๅŽๅ…น่ทฏไธ€ๅท,ๅฐ”ๆนพ,CA 92614,็พŽๅ›ฝ
Recent MDACS Registrations
Latest 15 devices linked to this applicant.
DeviceRisk ClassAuthorised RepRegistered
Prostheses, Cardiac Valve, Biological
ๅ‡ไฝ“, ๅฟƒ่„็“ฃ่†œ, ็”Ÿ็‰ฉ
IV
Edwards Lifesciences Hong Kong Limited
Jul 16, 2024
Prostheses, Cardiac Valve, Biological
ๅ‡ไฝ“, ๅฟƒ่„็“ฃ่†œ, ็”Ÿ็‰ฉ
IV
Edwards Lifesciences Hong Kong Limited
Jun 06, 2024
Prostheses, Cardiac Valve, Biological
ๅ‡ไฝ“, ๅฟƒ่„็“ฃ่†œ, ็”Ÿ็‰ฉ
IV
Edwards Lifesciences Hong Kong Limited
Dec 06, 2023
Prostheses, Cardiac Valve, Biological
ๅ‡ไฝ“, ๅฟƒ่„็“ฃ่†œ, ็”Ÿ็‰ฉ
IV
Edwards Lifesciences Hong Kong Limited
Aug 29, 2023
Transducers, Pressure, Disposable
ไผ ๆ„Ÿๅ™จ, ๅŽ‹ๅŠ›, ไธ€ๆฌกๆ€ง
II
Edwards Lifesciences Hong Kong Limited
Jul 12, 2023
Annuloplasty Ring/Band Implants
็Žฏๆˆๅฝขๆœฏ็Žฏ/ๅธฆ็Šถๆคๅ…ฅ็‰ฉ
IV
Edwards Lifesciences Hong Kong Limited
May 09, 2023
Annuloplasty Ring/Band Implants
็Žฏๆˆๅฝขๆœฏ็Žฏ/ๅธฆ็Šถๆคๅ…ฅ็‰ฉ
IV
Edwards Lifesciences Hong Kong Limited
Mar 03, 2023
Prostheses, Cardiac Valve, Biological
ๅ‡ไฝ“, ๅฟƒ่„็“ฃ่†œ, ็”Ÿ็‰ฉ
IV
Edwards Lifesciences Hong Kong Limited
Mar 03, 2023
Annuloplasty Ring/Band Implants
็Žฏๆˆๅฝขๆœฏ็Žฏ/ๅธฆ็Šถๆคๅ…ฅ็‰ฉ
IV
Edwards Lifesciences Hong Kong Limited
Nov 21, 2022
Monitors, Physiologic, Cardiac Output, Bedside
็›‘ๆŠคไปช, ็”Ÿ็†, ๅฟƒ่พ“ๅ‡บ้‡, ๅบŠ่พน
III
Edwards Lifesciences Hong Kong Limited
Nov 21, 2022
Monitoring Systems, Physiologic
็”Ÿ็†็›‘ๆต‹็ณป็ปŸ
III
Edwards Lifesciences Hong Kong Limited
Nov 04, 2022
Transducers, Pressure
ๅŽ‹ๅŠ›ไผ ๆ„Ÿๅ™จ
II
Edwards Lifesciences Hong Kong Limited
Nov 04, 2022
Monitors, Physiologic, Cardiac Output, Bedside
็›‘ๆŠคไปช, ็”Ÿ็†, ๅฟƒ่พ“ๅ‡บ้‡, ๅบŠ่พน
III
Edwards Lifesciences Hong Kong Limited
Nov 04, 2022
Cannulae, Femoral
ๆ’็ฎก,่‚ก้ชจ
II
Edwards Lifesciences Hong Kong Limited
Nov 04, 2022
Prostheses, Cardiac Valve, Biological
ๅ‡ไฝ“, ๅฟƒ่„็“ฃ่†œ, ็”Ÿ็‰ฉ
IV
DCH Auriga (Hong Kong) Limited
ๅฅฅๅˆฉไฝณ(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
Nov 09, 2017
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Risk Class Breakdown
II3
III3
IV10
Timeline
First Registration
Sep 23, 2015
Most Recent
Jul 16, 2024