Pure Global
80185
III
current

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This profile provides complete Hong Kong MDACS registration information for Hemodialysis Units, Renal, Continuous Replacement Therapy. 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, Renal, Continuous Replacement Therapy

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
23426
Product Code Detail
23426 Hemodialysis Units, Renal, Continuous Replacement Therapy
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Gambro Lundia AB
Gambro Lundia AB
Sweden
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Box 10101, Magistratsvagen 16, SE-220, 10 Lund, Sweden
Box 10101, Magistratesvagen 16, SE-220, 10 ้š†ๅพท, ็‘žๅ…ธ
Authorised Representative (AR)
Baxter Healthcare Ltd.
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34053000
Regulatory Timeline
Registration Date
November 26, 2023
Expiry Date
November 26, 2028
Product Models
Prismaflex (114489, 114870, 955052)
ๆ™ฎ้‡Œๆ–ฏ้ฉฌ็ฆ่Žฑๅ…‹ๆ–ฏ (114489, 114870, 955052)