150337
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)
DiaMed Holding GmbH
DiaMed Holding GmbH
Switzerland
็ๅฃซ
Pra Rond 23, 1785 Cressier FR, Switzerland
Pra Rond 23, 1785 ๅ
้ท่ฅฟ่ถ่้ฆๅ
ฌๆฅ, ็ๅฃซ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
November 11, 2020
Expiry Date
November 11, 2025
Product Models
Bio-Rad ABO/Rh (50001), DiaClon ABO/Rh for Patients (50012), ABO/RhD (50031), ABO/Rh for Newborns (50061), DiaClon ABO/Rh for New Borns DVI- (50071), ABO/D + Reverse Grouping (50081), DiaClonABO/D + Reverse Grouping (50092), DiaClon ABO/D (50481), DiaClon ABO/D + DAT (50492), DiaClon ABO/Rh for Newborns DVI + (50961), DiaClon ABO/Rh for Donors (51011)
Bio-Rad ABO/Rh (50001), DiaClon ABO/Rh ๆฃ่
(50012), ABO/RhD (50031), ABO/Rh ๆฐ็ๅฟ (50061), DiaClon ABO/Rh ๆฐ็ๅฟ DVI- (50071), ABO/D + ๅๅๅ็ป (50081), DiaClonABO/D + ๅๅๅ็ป (50092), DiaClon ABO/D (50481), DiaClon ABO/D + DAT (50492), DiaClon ABO/Rh ็จไบๆฐ็ๅฟ DVI+ (50961), DiaClon ABO/Rh ไพไฝ (51011)