220240
III
current
Hemodialysis Units่กๆถฒ้ๆๅไฝ
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
็ขๅ่ณ่จ๏ผ ่กๆถฒ้ๆๅไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
11218
Product Code Detail
11218 Hemodialysis Units
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
NxStage Medical, Inc
NxStage Medical, Inc
United States
็พๅฝ
350 Merrimack Street, Lawrence, Massachusetts 01843, United States
350 Merrimack Street, ๅณไผฆๆฏ, ้ฉฌ่จ่ฏธๅกๅท 01843, ็พ
Authorised Representative (AR)
Fresenius Medical Care Hong Kong Limited
่ดนๆฃฎๅฐคๆฏๅป่ฏ้ฆๆธฏๆ้ๅ
ฌๅธ
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 (CARโ172โC), PureFlow SL Purification Pack (PAKโ001)
NxStage System One ๅพช็ฏไปช (NX1000-3-A)ใPureFlow SL ้ๆๆถฒ่ขๆต็ผฉ็ฉ (SAK-304-A)ใNxStage System One ๆปค่ฏ (CAR-172โC)ใPureFlow SL ็บฏๅๅ
(PAK-001)