210434
Circulatory Assist Units, Cardiac, Ventricular
循环辅助单元,心脏,心室
Abiomed, Inc.·IV·Hong Kong MDACS·Registered January 17, 2022
Device overview
- Risk class
- IV
- Product code
- 10847
- State
- current
- Status
- N/A
- Product code detail
- 10847 Circulatory Assist Units, Cardiac, Ventricular
Manufacturer (製造商)
- Name
- Abiomed, Inc.Abiomed, Inc.
- Country
- United States美国
- Address
- 22 Cherry Hill Drive, Danvers, MA 01923, United States of America22 Cherry Hill Drive, 丹弗斯, MA 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
- January 17, 2022
- Expiry date
- January 17, 2027
Product models
Impella 5.0 (0046-3114), Silicon Plug (0046-3028), Impella Guidewire 0.018 (0052-3005), Impella Purge Cassette (0043-0009), Connector Cable Pump/Impella Controller (0042-0002)
Impella 5.0 (0046-3114), 硅插头 (0046-3028), Impella 导丝 0.018 (0052-3005), Impella 吹扫盒 (0043-0009), 连接器电缆泵/Impella 控制器 (0042-0002)
About this record
This profile provides complete Hong Kong MDACS registration information for Circulatory Assist Units, Cardiac, Ventricular. 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, Ventricular
產品資訊： 循环辅助单元,心脏,心室