240109
III
current
Hemodialysis Units่กๆถฒ้ๆๅไฝ
This profile provides complete Hong Kong MDACS registration information for Hemodialysis Units. 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: Hemodialysis Units
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
11218
Product Code Detail
11218 Hemodialysis Units
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Nuwellis, Inc.
Nuwellis, Inc.
12988 Valley View Road, MN 55344 Eden Prairie UNITED STATES
12988 Valley View Road, MN 55344 ไผ็ธ่ๅ, ็พๅฝ
Authorised Representative (AR)
21074668
Regulatory Timeline
Registration Date
April 03, 2024
Expiry Date
April 02, 2029
Product Models
Aquadex SmartFlow Console (120200), Aquadex SmartFlow Cart (420000), AquaFlexFlow UF 500 (114157), AquaFlexFlow UF 500 Plus (114156), Dual Lumen Extended Length Catheter (114153), Dual Lumen Extended Length Catheter and GALT Insertion Kit (115463)
Aquadex SmartFlow ๆงๅถๅฐ (120200)ใAquadex SmartFlow ๆจ่ฝฆ (420000)ใAquaFlexFlow UF 500 (114157)ใAquaFlexFlow UF 500 Plus (114156)ใๅ่
้ฟๅฏผ็ฎก (114153)ใๅ่
้ฟๅฏผ็ฎกๅ GALT ๆๅ
ฅๅฅไปถ (115463)