Authorised representative (AR)

Beckman Coulter Hong Kong Limited

贝克曼库尔特香港有限公司

Hong Kong MDACS·35 represented devices·3 applicants·Nov 18, 2020 – Sep 24, 2024

Total devices

Applicants

2020

First representation

2024

Most recent

AR overview

Bilingual authorised representative information and contact details

Authorised representative (EN): Beckman Coulter Hong Kong Limited
Authorised representative (ZH): 贝克曼库尔特香港有限公司
Phone: 28147431

Timeline

First representation: Nov 18, 2020
Most recent: Sep 24, 2024

Risk class distribution

Applicant partnerships

Top manufacturers represented by this AR

Beckman Coulter, Inc.

Immunotech SAS, A Beckman Coulter Company

Immunotech S.A.S., A Beckman Coulter Company

Recent registrations

Latest 15 MDACS listings represented by Beckman Coulter Hong Kong Limited

Device	Risk class	Applicant	Registered
IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin, Beta 体外诊断检测试剂/试剂盒, 免疫测定, 妊娠激素, 人绒毛膜促性腺激素, β	C	Beckman Coulter, Inc. Beckman Coulter, Inc.	Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Prolactin 体外诊断测试试剂/试剂盒、免疫测定、生育激素、催乳素	C	Beckman Coulter, Inc. Beckman Coulter, Inc.	Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroglobulin 体外诊断检测试剂/试剂盒、免疫测定、甲状腺激素、甲状腺球蛋白	C	Beckman Coulter, Inc. Beckman Coulter, Inc.	Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone 体外诊断测试试剂/试剂盒、免疫测定、生育激素、促卵泡激素	B	Beckman Coulter, Inc. Beckman Coulter, Inc.	Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing Hormone 体外诊断检测试剂/试剂盒,免疫测定,生育激素,黄体生成素	B	Beckman Coulter, Inc. Beckman Coulter, Inc.	Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin 体外诊断测试试剂/试剂盒、免疫测定、甲状腺激素、促甲状腺素	B	Immunotech SAS, A Beckman Coulter Company Beckman Coulter, Inc.	Sep 20, 2024
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125 体外诊断测试试剂/试剂盒、免疫测定、肿瘤标志物、碳水化合物抗原 CA 125	C	Beckman Coulter, Inc. Beckman Coulter, Inc.	Aug 08, 2024
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, Free 体外诊断检测试剂/试剂盒,免疫测定,甲状腺激素,甲状腺素,游离	B	Beckman Coulter, Inc. Beckman Coulter, Inc.	Aug 08, 2024
IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin 体外诊断测试试剂/试剂盒、免疫测定、心脏标志物、蛋白质、肌红蛋白	B	Beckman Coulter, Inc. Beckman Coulter, Inc.	Aug 08, 2024
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen 体外诊断检测试剂/试剂盒、免疫测定、肿瘤标志物、酶、前列腺特异性抗原	C	Beckman Coulter, Inc. Beckman Coulter, Inc.	Aug 08, 2024
IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Peroxidase Antibody 体外诊断检测试剂/试剂盒、免疫分析、自身免疫、甲状腺、过氧化物酶抗体	B	Beckman Coulter, Inc. Beckman Coulter, Inc.	Aug 08, 2024
IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin 体外诊断测试试剂/试剂盒、免疫测定、蛋白质、降钙素原	B	Immunotech SAS, A Beckman Coulter Company Beckman Coulter, Inc.	Jul 24, 2024
IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Bone Alkaline Phosphatase 体外诊断测试试剂/试剂盒、免疫测定、骨代谢标志物、骨碱性磷酸酶	B	Beckman Coulter, Inc. Beckman Coulter, Inc.	Jul 24, 2024
IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin 体外诊断检测试剂/试剂盒、免疫测定、贫血检测、促红细胞生成素	B	Beckman Coulter, Inc. Beckman Coulter, Inc.	Jul 24, 2024
IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol 体外诊断测试试剂/试剂盒、免疫测定、肾脏代谢、皮质醇	B	Beckman Coulter, Inc. Beckman Coulter, Inc.	Jul 24, 2024

About this profile

Beckman Coulter Hong Kong Limited serves as the authorised representative for 35 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.