210434
IV
current
Circulatory Assist Units, Cardiac, Ventricularๅพช็ฏ่พ ๅฉๅๅ ,ๅฟ่,ๅฟๅฎค
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
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
10847
Product Code Detail
10847 Circulatory Assist Units, Cardiac, Ventricular
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Abiomed, Inc.
Abiomed, Inc.
United States
็พๅฝ
22 Cherry Hill Drive, Danvers, MA 01923, United States of America
22 Cherry Hill Drive, ไธนๅผๆฏ, MA 01923, ็พๅฝ
Authorised Representative (AR)
DCH Auriga (Hong Kong) Limited
ๅฅฅๅฉไฝณ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
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), ็ก
ๆๅคด (0046-3028), Impella ๅฏผไธ 0.018 (0052-3005), Impella ๅนๆซ็ (0043-0009), ่ฟๆฅๅจ็ต็ผๆณต/Impella ๆงๅถๅจ (0042-0002)