150102
III
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
III
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
ๅฐๆณฐๆ, BP 126, 69883 ๆข
้ฝๅๅก่ฟชๅ
ๆฏ, ๆณๅฝ
Authorised Representative (AR)
Baxter Healthcare Ltd.
็พ็นๅป็็จๅๆ้ๅ
ฌๅธ
34053000
Regulatory Timeline
Registration Date
April 30, 2020
Expiry Date
April 30, 2025
Product Models
Prismaflex Sets HF 1000 (107140), Prismaflex Sets HF 1400 (107142)
ๆฎ็ๆฏ้ฉฌ็ฆ่ฑๅ
ๆฏๅฅไปถ HF 1000 (107140), ๆฎ้ๆฏ้ฉฌๆๆงๅฅไปถ HF 1400 (107142)