IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Glucose, Strip

体外诊断检测试剂/试剂盒、临床化学、快速检测、全血、葡萄糖、试纸

Roche Diabetes Care GmbH·C·Hong Kong MDACS·Registered February 08, 2023

Device overview

Risk class: C
Product code: 17419
State: current
Status: N/A
Product code detail: 17419 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Glucose, Strip

Manufacturer (製造商)

Name: Roche Diabetes Care GmbH
Roche Diabetes Care Gmbh
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: February 08, 2023
Expiry date: February 08, 2028

Product models

Accu-Chek Performa test strips (06454003020, 06454011020, 06454038020)

Accu-Chek Performa试纸条(06454003020,06454011020,06454038020)

About this record

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

產品資訊： 体外诊断检测试剂/试剂盒、临床化学、快速检测、全血、葡萄糖、试纸