210382
IV
current
Catheters, Cardiacๅฏผ็ฎก,ๅฟ่
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
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
10698
Product Code Detail
10698 Catheters, Cardiac
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Abiomed Inc.
Abiomed Inc.
United States
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22 Cherry Hill Drive, Danvers, MA 21923, United States of America
22 Cherry Hill Drive, ไธนๅผๆฏ, MA 21923, ็พๅฝ
Authorised Representative (AR)
DCH Auriga (Hong Kong) Limited
ๅฅฅๅฉไฝณ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
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 ๅธฆๆบ่ฝ่พ
ๅฉ (0550-0007)ใImpella ๅฏผไธ 0.018 (0052-3005)ใImpella ๅนๆซ็ (0043-0009)ใ็ก
่ถๆๅคด (0046-3028)