Authorised representative (AR)

POTUS Medical (Hong Kong) Limited

Hong Kong MDACS·7 represented devices·4 applicants·Feb 25, 2022 – Sep 24, 2024

Total devices

Applicants

2022

First representation

2024

Most recent

AR overview

Bilingual authorised representative information and contact details

Authorised representative (EN): POTUS Medical (Hong Kong) Limited
Phone: 39552662

Timeline

First representation: Feb 25, 2022
Most recent: Sep 24, 2024

Risk class distribution

Applicant partnerships

Top manufacturers represented by this AR

AESKU.Diagnostics GmbH & Co. KG

SD Biosensor, Inc.

Seegene Inc.

InTec PRODUCTS, INC.

Recent registrations

Latest 15 MDACS listings represented by POTUS Medical (Hong Kong) Limited

Device	Risk class	Applicant	Registered
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria 体外诊断检测试剂/试剂盒, 分子检测, 感染, 细菌	C	Seegene Inc. Seegene Inc.	Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Legionella pneumophila, Antigen 体外诊断检测试剂/试剂盒, 免疫测定, 快速检测, 细菌, 嗜肺军团菌, 抗原	C	SD Biosensor, Inc. Sd Biosensor,Inc.	Sep 11, 2024
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigen 体外诊断检测试剂/试剂盒, 免疫测定, 快速检测, 细菌, 肺炎链球菌, 抗原	C	SD Biosensor, Inc. Sd Biosensor,Inc.	Sep 11, 2024
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus 体外诊断检测试剂/试剂盒、分子检测、感染、病毒	B	Seegene Inc. Seegene Inc.	Sep 09, 2024
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Virus Severe Acute Respiratory Syndrome Coronavirus 2, Antigen 体外诊断检测试剂/试剂盒、免疫测定、快速检测、病毒严重急性呼吸综合征冠状病毒2、抗原	C	InTec PRODUCTS, INC. 英科新创（厦门）科技股份有限公司	Nov 03, 2022
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	C	AESKU.Diagnostics GmbH & Co. KG Aesku.Diagnostics Gmbh&Co.Kg	May 16, 2022
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	C	AESKU.Diagnostics GmbH & Co. KG Aesku.Diagnostics Gmbh&Co.Kg	Feb 25, 2022

About this profile

POTUS Medical (Hong Kong) Limited serves as the authorised representative for 7 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.