240109
Hemodialysis Units
血液透析单位
Nuwellis, Inc.·III·Hong Kong MDACS·Registered April 03, 2024
Device overview
- Risk class
- III
- Product code
- 11218
- State
- current
- Status
- N/A
- Product code detail
- 11218 Hemodialysis Units
Manufacturer (製造商)
- Name
- Nuwellis, Inc.Nuwellis, Inc.
- Address
- 12988 Valley View Road, MN 55344 Eden Prairie UNITED STATES12988 Valley View Road, MN 55344 伊甸草原, 美国
Authorised representative (AR)
- Phone
- 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 控制台 (120200)、Aquadex SmartFlow 推车 (420000)、AquaFlexFlow UF 500 (114157)、AquaFlexFlow UF 500 Plus (114156)、双腔长导管 (114153)、双腔长导管和 GALT 插入套件 (115463)
About this record
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
產品資訊： 血液透析单位