Authorised representative profile

Beckman Coulter Hong Kong Limited

贝克曼库尔特香港有限公司

Hong Kong MDACS35 represented devices3 applicantsNov 18, 2020 – Sep 24, 2024

VerifiedMDD (Medical Device Division) · MDACS registry

35

Total devices

3

Applicants

2020

First representation

2024

Most recent

AR overview

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

Regulatory footprint

Search Beckman Coulter Hong Kong Limited across other regulatory registries

Risk class distribution

B22

C9

D4

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

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

Risk class: C
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: C
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: C
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: B
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: B
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: B
Applicant: Immunotech SAS, A Beckman Coulter CompanyBeckman Coulter, Inc.

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

Risk class: C
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: B
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: B
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: C
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: B
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: B
Applicant: Immunotech SAS, A Beckman Coulter CompanyBeckman Coulter, Inc.

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

Risk class: B
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: B
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

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

Risk class: B
Applicant: Beckman Coulter, Inc.Beckman Coulter, Inc.

View all 35 devices →

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.