220240
Hemodialysis Units
血液透析单位
NxStage Medical, Inc·III·Hong Kong MDACS·Registered March 03, 2023
Device overview
- Risk class
- III
- Product code
- 11218
- State
- current
- Status
- N/A
- Product code detail
- 11218 Hemodialysis Units
Manufacturer (製造商)
- Name
- NxStage Medical, IncNxStage Medical, Inc
- Country
- United States美国
- Address
- 350 Merrimack Street, Lawrence, Massachusetts 01843, United States350 Merrimack Street, 劳伦斯, 马萨诸塞州 01843, 美
Authorised representative (AR)
- Name
- Fresenius Medical Care Hong Kong Limited费森尤斯医药香港有限公司
- Phone
- 26068000
Regulatory timeline
- Registration date
- March 03, 2023
- Expiry date
- August 18, 2027
Product models
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)
NxStage System One 循环仪 (NX1000-3-A)、PureFlow SL 透析液袋浓缩物 (SAK-304-A)、NxStage System One 滤芯 (CAR-172‐C)、PureFlow SL 纯化包 (PAK-001)
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