Medical Device Division · registration 240109ActiveNuwellis
Hong KongHemodialysis UnitsClass IIINuwellis, Inc.
Official record identity
- MDACS listing number
- 240109
- Model name
- 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)
- Registration date
- April 03, 2024
- Expiry date
- April 02, 2029
- Source update date
- May 06, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Transmedic China Limited
- Manufacturer
- Nuwellis, 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, MN 55344 Eden Prairie UNITED STATES
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.