240421
B
current
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Androstenedioneไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ็่ฒๆฟ็ด , ้็ฏไบ้ ฎ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Androstenedione. 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, Immunoassay, Fertility Hormone, Androstenedione
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ็่ฒๆฟ็ด , ้็ฏไบ้ ฎ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19867
Product Code Detail
19867 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Androstenedione
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Germany
ๅพทๅฝ
Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 ๆผๆตทๅง, ๅพทๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
Elecsys Androstenedione (07679840190, 07679831190), CalSet Androstenedione (07679866190)
Elecsys Androstenedione (07679840190, 07679831190), CalSet Androstenedione (07679866190)