Medical Device Division · registration 220240ActiveNxStage Medical
Hong KongHemodialysis UnitsClass IIINxStage Medical, Inc
Official record identity
- MDACS listing number
- 220240
- Model name
- NxStage System One Cycler (NX1000-3-A), PureFlow SL Dialysate Sack Concentrate (SAK-304-A), NxStage System One Cartridge (CAR‐172‐C), PureFlow SL Purification Pack (PAK‐001)
- Registration date
- March 03, 2023
- Expiry date
- August 18, 2027
- Source update date
- April 11, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Fresenius Medical Care Hong Kong Limited
- Manufacturer
- NxStage Medical, Inc
Official description
Hemodialysis Units
Additional source fields
- AMD nomenclature code
- 11218
- Local responsible person phone
- 26068000
- Published manufacturer address
- 350 Merrimack Street, Lawrence, Massachusetts 01843, United States
- Revision number
- a
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.