Pure Global
220070

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

体外诊断 检测试剂/试剂盒、血清学、快速检测、病毒、严重急性呼吸综合征冠状病毒 2
AESKU.Diagnostics GmbH & Co. KG·C·Hong Kong MDACS·Registered February 25, 2022
Device overview
Risk class
C
Product code
41572
State
N/A
Status
N/A
Product code detail
41572 IVD Test Reagent/Kits, Rapid Test, Virus, Severe Acute Respiratory Syndrome Coronavirus 2
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
February 25, 2022
Expiry date
February 25, 2027
Product models
AESKU.RAPID SARS-CoV-2 (840001, 840003, 840005)
艾斯库.快速SARS-CoV-2(840001年、840003年840005年)
About this record

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

產品資訊： 体外诊断 检测试剂/试剂盒, 快速检测, 病毒, 严重急性呼吸综合征冠状病毒 2