220152

IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen

体外诊断检测试剂/试剂盒、血清学、病毒、严重急性呼吸综合征冠状病毒2、抗原

AESKU.Diagnostics GmbH & Co. KG·C·Hong Kong MDACS·Registered May 16, 2022

Device overview

Risk class: C
Product code: 41618
State: current
Status: N/A
Product code detail: 41618 IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen

Manufacturer (製造商)

Name: AESKU.Diagnostics GmbH & Co. KG
Aesku.Diagnostics Gmbh&Co.Kg
Country: Germany
德国
Address: Mikroforum Ring 2, 55234 Wendelsheim, Germany
Mikroforum Ring 2, 55234 文德尔斯海姆, 德国

Authorised representative (AR)

Name: POTUS Medical (Hong Kong) Limited
Phone: 39552662

Regulatory timeline

Registration date: May 16, 2022
Expiry date: May 16, 2027

Product models

AESKU.RAPID SARS-CoV-2 (840005E, 840003E, 840001E)

艾斯库.快速SARS-CoV-2(840005E,840003E,840001E)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen. 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, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen

產品資訊： 体外诊断检测试剂/试剂盒、血清学、病毒、严重急性呼吸综合征冠状病毒2、抗原