100225
D
Delisted
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigenไฝๅค่ฏๆญ่ฏๅ/่ฏๅ็๏ผ่กๆธ ๅญฆ๏ผ็ ๆฏ๏ผไนๅ่็๏ผ่กจ้ขๆๅ
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 ไฝๅค่ฏๆญ่ฏๅ/่ฏๅ็๏ผ่กๆธ ๅญฆ๏ผ็ ๆฏ๏ผไนๅ่็๏ผ่กจ้ขๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17360
State
N/A
Status
Delisted
ๅทฒ้ๅธ
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Products GmbH
Siemens Healthineers
Germany
ๅพทๅฝ
Emil-Von-Behring-Str. 76, 35041 Marburg, Deutschland
ๅพทๅฝ้ฉฌๅฐๅ ก๏ผEmil-Von-Behring-Str. 76๏ผ้ฎๆฟ็ผ็ 35041
Authorised Representative (AR)
Siemens Limited
่ฅฟ้จๅญๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
July 08, 2010
Expiry Date
July 08, 2015
Delist Date
April 23, 2015
Remarks
Delisted.
ๅทฒๅพๅ่กจไธญๅช้คใ
Product Models
Enzygnost HBsAg 6.0