IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone

体外诊断测试试剂/试剂盒、免疫测定、生育激素、促卵泡激素

Roche Diagnostic GmbH·B·Hong Kong MDACS·Registered August 16, 2024

Device overview

Risk class: B
Product code: 19116
State: current
Status: N/A
Product code detail: 19116 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone

Manufacturer (製造商)

Name: Roche Diagnostic 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: August 16, 2024
Expiry date: April 27, 2028

Product models

Elecsys FSH (08932352190, 08932387190, 08932387214)), FSH CalSet II (08932417190, 09557440190)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone. 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, Follicle Stimulating Hormone

產品資訊： 体外诊断测试试剂/试剂盒、免疫测定、生育激素、促卵泡激素