230275
II
current
Catheter Introducersๅฏผ็ฎกไป็ปๅจ
This profile provides complete Hong Kong MDACS registration information for Catheter Introducers. 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: Catheter Introducers
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกไป็ปๅจ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
34021
Product Code Detail
34021 Catheter Introducers
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
August 24, 2023
Expiry Date
August 24, 2028
Product Models
Impella CP Introducer Kit (0052-3046, 0052-3053, 0052-3052, 0052-0038, 0052-0039)
Impella CP ๅฏผๅ
ฅๅจๅฅไปถ (0052-3046, 0052-3053, 0052-3052, 0052-0038, 0052-0039)