IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin

体外诊断测试试剂/试剂盒、免疫测定、妊娠激素、人绒毛膜促性腺激素

Roche Diagnostics GmbH·B·Hong Kong MDACS·Registered September 24, 2024

Device overview

Risk class: B
Product code: 19123
State: current
Status: N/A
Product code detail: 19123 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin

Manufacturer (製造商)

Name: Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Country: Germany
德国
Address: Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 曼海姆, 德国

Authorised representative (AR)

Name: Roche Diagnostics (Hong Kong) Limited
Phone: 24813387

Regulatory timeline

Registration date: September 24, 2024
Expiry date: September 23, 2029

Product models

HCG STAT CalSet (09013296190), Elecsys HCG STAT (08890595190, 08890587190)

HCG 统计 CalSet (09013296190), Elecsys HCG 统计 (08890595190, 08890587190)

About this record

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

產品資訊： 体外诊断测试试剂/试剂盒、免疫测定、妊娠激素、人绒毛膜促性腺激素