180162
Circulatory Assist Units, Cardiac
循环辅助装置,心脏
Abiomed Inc.·III·Hong Kong MDACS·Registered August 29, 2023
Device overview
- Risk class
- III
- Product code
- 10840
- State
- current
- Status
- N/A
- Product code detail
- 10840 Circulatory Assist Units, Cardiac
Manufacturer (製造商)
- Name
- Abiomed Inc.Abiomed Inc.
- Country
- United States美国
- Address
- 22 Cherry Hill Drive, Danvers, Massachusetts 01923, USA22 樱桃山大道, 丹弗斯, 马萨诸塞州 01923, 美国
Authorised representative (AR)
- Name
- DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
- Phone
- 36192800
Regulatory timeline
- Registration date
- August 29, 2023
- Expiry date
- June 11, 2028
Product models
Automated Impella Controller (0042-0010), Impella Connect (0042-4100), Automated Impella controller with Impella Connect (0042-0040)
自动Impella控制器(0042-0010),Impella连接(0042-4100),带Impella连接的自动Impella控制器(0042-0040)
About this record
This profile provides complete Hong Kong MDACS registration information for Circulatory Assist Units, Cardiac. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Circulatory Assist Units, Cardiac
產品資訊： 循环辅助装置,心脏