Medical Device Division · registration 210008ExpiredCHF Solutions
Hong KongHemodialysis UnitsClass IIICHF Solutions, Inc.
Official record identity
- MDACS listing number
- 210008
- Model name
- Aquadex SmartFlow Console (120200), Aquadex SmartFlow Cart (420000), AquaFlexFlow UF 500 (114157), AquaFlexFlow UF 500 Plus (114156)
- Registration date
- February 03, 2021
- Expiry date
- February 03, 2026
- Source update date
- July 07, 2023
- Status
- Expired
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Transmedic China Limited
- Manufacturer
- CHF Solutions, Inc.
Official description
Hemodialysis Units
Additional source fields
- AMD nomenclature code
- 11218
- Traditional Chinese local responsible person
- 傳新中國有限公司
- Local responsible person phone
- 21074668
- Published manufacturer address
- 12988 Valley View Road Eden Prairie, MN 55344, USA
- Published remarks
- Expired.
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.