220258
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen. 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, Serology, Virus, Hepatitis B, Surface Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17360
Product Code Detail
17360 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BioMerieux S.A.
Biomรฉrieux
376, Chemin de l'Orme, 69280 MARCY L ETOILE, FRANCE
376, Chemin de l'Orme, 69280 MARCY L ETOILE, ่้ฆๅ
ฌๆฅ ANCE
Authorised Representative (AR)
BioMerieux China Ltd.
็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ
23567033
Regulatory Timeline
Registration Date
August 31, 2022
Expiry Date
August 31, 2027
Product Models
VIDAS HBs Ag Ultra (30315)
็ๆดป HB ๅไธ่ถ
(30315)