180162
III
current
Circulatory Assist Units, Cardiacๅพช็ฏ่พ ๅฉ่ฃ ็ฝฎ,ๅฟ่
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
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
10840
Product Code Detail
10840 Circulatory Assist Units, Cardiac
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Abiomed Inc.
Abiomed Inc.
United States
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22 Cherry Hill Drive, Danvers, Massachusetts 01923, USA
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Authorised Representative (AR)
DCH Auriga (Hong Kong) Limited
ๅฅฅๅฉไฝณ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
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)
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