110378
D
current
IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typingไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซ่กๆถฒๅญฆใ่กๅใABO ๅๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing. 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: IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซ่กๆถฒๅญฆใ่กๅใABO ๅๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19295
Product Code Detail
19295 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Diagast
Diagast
France
ๆณๅฝ
251, avenue Eugene Avinee, Eurasante Parc, 59120, LOOS, France
251 Eugene Avinee Avenue, Eurasante Park, 59120, LOOS, ๆณๅฝ
Authorised Representative (AR)
Mekim Limited
็พไฟญๆ้ๅ
ฌๅธ
27748300
Regulatory Timeline
Registration Date
October 18, 2021
Expiry Date
October 25, 2026
Product Models
ANTI-A, ANTI-B, ANTI-A,B, NEG CONTROL (70501, 70502, 70503, 79000)
้ฒ Aใ้ฒ Bใ้ฒ AใBใ่ดๆงๅถ(70501ใ70502ใ70503ใ79000)