IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine

体外诊断检测试剂/试剂盒, 临床化学, 快速检测, 尿液

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

Device overview

Risk class: B
Product code: 17480
State: current
Status: N/A
Product code detail: 17480 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine

Manufacturer (製造商)

Name: Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Country: Germany
德国
Address: Sandhofer Strasse 116, 68305 Manheim, 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

cobas u pack (06334601001)

COBAS Pack (06334601001)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine. 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, Clinical Chemistry, Rapid Test, Urine

產品資訊： 体外诊断检测试剂/试剂盒, 临床化学, 快速检测, 尿液