180163
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 Europe GmbH
Abiomed Europe GmbH
Germany
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Neuenhofer Weg 3, 52074 Aachen, Germany
Neuenhofer Weg 3, 52074 ไบ็, ๅพทๅฝ
Authorised Representative (AR)
DCH Auriga (Hong Kong) Limited
ๅฅฅๅฉไฝณ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
36192800
Regulatory Timeline
Registration Date
May 09, 2023
Expiry Date
June 11, 2028
Product Models
Impella 2.5 Set (005040), Impella CP Set (0048-0014, 0048-0002)
Impella 2.5 Sep (005040), Impella CP Set (0048-0014, 0048-0002)