170004
III
current
Dialyzers, Hemodialysis, Hollow-Fiber้ๆๅจใ่กๆถฒ้ๆใไธญ็ฉบ็บค็ปด
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
็ขๅ่ณ่จ๏ผ ้ๆๅจใ่กๆถฒ้ๆใไธญ็ฉบ็บค็ปด
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 Dialysatoren GmbH
Baxter
Germany
ๅพทๅฝ
Holger-Crafoord-Strasse 26, Hechingen 72379, Germany
้ๅฐๆ ผ-ๅ
ๆ็ฆๅพทๅคง่ก 26 ๅท, ่ตซๆฌฃๆ น 72379, ๅพทๅฝ
Authorised Representative (AR)
Baxter Healthcare Ltd.
็พ็นๅป็็จๅๆ้ๅ
ฌๅธ
34053000
Regulatory Timeline
Registration Date
December 10, 2021
Expiry Date
February 01, 2027
Product Models
Theranova 400 (115578), Theranova 500 (115579), Theranova 400 APAC (955367), Theranova 500 APAC (955368)
ๆณฐๆ่ฏบ็ฆ 400 (115578), ่ฒๆ่ฏบ็ฆ 500 (115579), ๆณฐๆ่ฏบ็ฆ 400 ไบๅคชๅฐๅบ (955367), ๆณฐๆ่ฏบ็ฆ 500 ไบๅคชๅฐๅบ (955368)