230501
C
current
IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Antiglobulin, Polyspecificไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซ่กๆถฒๅญฆ, ๆไฝๆฃๆต/้ดๅฎ, ๆไบบ็่็ฝ, ๅค็นๅผๆง
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Antiglobulin, Polyspecific. 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, Antibody Detection/Identification, Antiglobulin, Polyspecific
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซ่กๆถฒๅญฆ, ๆไฝๆฃๆต/้ดๅฎ, ๆไบบ็่็ฝ, ๅค็นๅผๆง
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19780
Product Code Detail
19780 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Antiglobulin, Polyspecific
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
DiaMed GmbH
Diamed Gmbh
Pra Rond 23, 175 Cressier FR, SWITZERLAND
Pra Rond 23, 175 ๅ
้ท่ฅฟ่ถ่้ฆๅ
ฌๆฅ, ็ๅฃซ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
December 22, 2023
Expiry Date
December 22, 2028
Product Models
LISS/Coombs (50531) (004014, 004015, 004016, 004017)
LISS/Coombs (50531) (004014, 004015, 004016, 004017)