2 Devices
HeartWare, Inc. - Applicant Profile
HeartWare, Inc.
HeartWare, Inc. is associated with 2 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.
1 Risk Classes
Since 2015
Latest 2018
Applicant Overview
Bilingual manufacturer details sourced from Hong Kong MDACS.
Applicant (EN)
HeartWare, Inc.
Country
United States
็พๅฝ
Applicant (ZH)
HeartWare, Inc.
Address
14400 NW 60th Avenue, Miami Lakes, Florida, 33014, USA
14400 NW 60th Avenue, ่ฟ้ฟๅฏๆนๅบ, ไฝ็ฝ้่พพๅท, 33014, ็พๅฝ
Recent MDACS Registrations
Latest 15 devices linked to this applicant.
| Device | Risk Class | Authorised Rep | Registered |
|---|---|---|---|
| Circulatory Assist Units, Cardiac, Ventricular ๅพช็ฏ่พ
ๅฉๅๅ
,ๅฟ่,ๅฟๅฎค | IV | Medtronic Hong Kong Medical Limited | Dec 06, 2018 |
| Circulatory Assist Units, Cardiac, Ventricular ๅพช็ฏ่พ
ๅฉๅๅ
,ๅฟ่,ๅฟๅฎค | IV | IntegMed Limited ่ฑ็นๆผๆ้ๅ
ฌๅธ | Aug 05, 2015 |
Risk Class Breakdown
IV2
Timeline
First Registration
Aug 05, 2015
Most Recent
Dec 06, 2018