Pure Global
150001
III
Expired.

Hemodialysis Units่ก€ๆถฒ้€ๆžๅ•ไฝ

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

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
11218
Product Code Detail
11218 Hemodialysis Units
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
NxStage Medical, Inc
NxStage Medical, Inc
United States
็พŽๅ›ฝ
350 Merrimack Street, Lawrence, Massachusetts, 01843, USA
350 Merrimack Street, ๅŠณไผฆๆ–ฏ, ้ฉฌ่จ่ฏธๅกžๅทž, 01843, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
February 27, 2015
Expiry Date
February 27, 2020
Product Models
System One (NX1000-1, NX0642, FW-300-WW, FW-300-1, NX2000-1, NX2000-2ยฌEU, NX2000-4, PAK-001, SAK-301, SAK-302, SAK-303, SAK-304, SAK-305, CAR-172-WW, CAR-124-C, RFP-204, RFP-204-WW, RFP-205, RFP-205-WW, RFP-207, RFP-207-WW, RFP-209, RFP-209-WW, FWS-304-WW, FWS-308-WW, FWS-206-B, FWS-209-B, ANC-101, ANC-200, NX2000-6, DTK-001, BH-2004PE, BH-2007PE, BH-2035PE, BH-2036PE, BH-2037PE, BH-3005, BH-4005PE, BH-4006PE, BH-7004PE, BH-7015, BH-7605PE, BH-7606PE, NX-2000-8-EU)
็ณป็ปŸไธ€ (NX1000-1, NX0642, ๅ›บไปถ-300-WW, ๅ›บไปถ-300-1, NX2000-1, NX2000-2ยฌEU, NX2000-4, PAK-001, SAK-301, SAK-302, SAK-303, SAK-304, SAK-305, CAR-172-WW, CAR-124-C, RFP-204, RFP-204-WW, RFP-205, RFP-205-WW, RFP-207, RFP-207-WW, RFP-209, RFP-209-WW , FWS-304-WW, FWS-308-WW, FWS-206-B, FWS-209-B, ANC-101, ANC-200, NX2000-6, DTK-001, BH-2004PE, BH-2007PE, BH-2035PE, BH-2036PE, BH-2037PE, BH-3005, BH-4005PE, BH-4006PE, BH-7004PE, BH-7015, BH-7605PE, BH-7606PE, NX-2000-8-EU)