140155
IV
current
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This profile provides complete Hong Kong MDACS registration information for Dialyzers, Hemodialysis, Hollow-Fiber. 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: Dialyzers, Hemodialysis, Hollow-Fiber
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
11234
Product Code Detail
11234 Dialyzers, Hemodialysis, Hollow-Fiber
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Gambro Industries
Gambro Industries
France
ๆณๅฝ
7, Avenue Lionel Terray, BP 126, 69883 Meyzieu Cedex, France
7, ๅคง้่ฑๆๅ
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ๆฏ, ๆณๅฝ
Authorised Representative (AR)
Baxter Healthcare Ltd.
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ฌๅธ
34053000
Regulatory Timeline
Registration Date
April 03, 2024
Expiry Date
June 17, 2029
Product Models
oXiris - Prismaflex Set (112016), oXiris - S Prismaflex Set (955503)
oXiris - Prismaflex Set (112016), oXiris - S Prismaflex Set (955503)