241049
B
current
IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropinไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใๅฆๅจ ๆฟ็ด ใไบบ็ปๆฏ่ไฟๆง่ บๆฟ็ด
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin. 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, Pregnancy Hormone, Human Chorionic Gonadotropin
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใๅฆๅจ ๆฟ็ด ใไบบ็ปๆฏ่ไฟๆง่ บๆฟ็ด
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19123
Product Code Detail
19123 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin
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
HCG STAT CalSet (09013296190), Elecsys HCG STAT (08890595190, 08890587190)
HCG ็ป่ฎก CalSet (09013296190), Elecsys HCG ็ป่ฎก (08890595190, 08890587190)