210382
Catheters, Cardiac
导管,心脏
Abiomed Inc.·IV·Hong Kong MDACS·Registered December 03, 2021
Device overview
- Risk class
- IV
- Product code
- 10698
- State
- current
- Status
- N/A
- Product code detail
- 10698 Catheters, Cardiac
Manufacturer (製造商)
- Name
- Abiomed Inc.Abiomed Inc.
- Country
- United States美国
- Address
- 22 Cherry Hill Drive, Danvers, MA 21923, United States of America22 Cherry Hill Drive, 丹弗斯, MA 21923, 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
- December 03, 2021
- Expiry date
- December 03, 2026
Product models
Impella 5.5 with Smart Assist (0550-0007), Impella Guidewire 0.018 (0052-3005), Impella Purge Cassette (0043-0009), Silicone Plug (0046-3028)
Impella 5.5 带智能辅助 (0550-0007)、Impella 导丝 0.018 (0052-3005)、Impella 吹扫盒 (0043-0009)、硅胶插头 (0046-3028)
About this record
This profile provides complete Hong Kong MDACS registration information for Catheters, 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: Catheters, Cardiac
產品資訊： 导管,心脏