Applicant profile
HeartWare, Inc.
HeartWare, Inc.
Hong Kong MDACS·United States·2 registered devices·Aug 05, 2015 – Dec 06, 2018
2
Total devices
1
Risk classes
2015
First registration
2018
Most recent
Applicant overview
Bilingual manufacturer details sourced from Hong Kong MDACS
- Applicant (EN)
- HeartWare, Inc.
- Applicant (ZH)
- HeartWare, Inc.
- Country
- United States美国
- Address
- 14400 NW 60th Avenue, Miami Lakes, Florida, 33014, USA14400 NW 60th Avenue, 迈阿密湖区, 佛罗里达州, 33014, 美国
Timeline
- First registration
- Aug 05, 2015
- Most recent
- Dec 06, 2018
Risk class breakdown
IV
2
Recent MDACS registrations
Latest 15 devices linked to this applicant
| Device | Risk class | Authorised rep | Registered |
|---|---|---|---|
| Circulatory Assist Units, Cardiac, Ventricular 循环辅助单元,心脏,心室 | IV | Medtronic Hong Kong Medical Limited | Dec 06, 2018 |
| Circulatory Assist Units, Cardiac, Ventricular 循环辅助单元,心脏,心室 | IV | IntegMed Limited 英特曼有限公司 | Aug 05, 2015 |
About this profile
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.