32 Devices

Beckman Coulter, Inc. - Applicant Profile

Beckman Coulter, Inc.

Beckman Coulter, Inc. is associated with 32 medical devices registered under the Hong Kong Medical Device Administrative Control System (MDACS). Explore bilingual product names, risk classes, authorised representatives, and life-cycle milestones.

3 Risk Classes

Since 2020

Latest 2024

Applicant Overview

Bilingual manufacturer details sourced from Hong Kong MDACS.

Applicant (EN)

Beckman Coulter, Inc.

Country

United States

美国

Applicant (ZH)

Beckman Coulter, Inc.

Address

250 South Kraemer Blvd., Brea, California, 92821, USA

250南克雷默大道,布雷亚,加利福尼亚州,92821,美国

Recent MDACS Registrations

Latest 15 devices linked to this applicant.

Device	Risk Class	Authorised Rep	Registered
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 Hong Kong Limited 贝克曼库尔特香港有限公司	Sep 24, 2024
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 Hong Kong Limited 贝克曼库尔特香港有限公司	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 Hong Kong Limited 贝克曼库尔特香港有限公司	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 Hong Kong Limited 贝克曼库尔特香港有限公司	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 Hong Kong Limited 贝克曼库尔特香港有限公司	Sep 24, 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 Hong Kong Limited 贝克曼库尔特香港有限公司	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 Hong Kong Limited 贝克曼库尔特香港有限公司	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 Hong Kong Limited 贝克曼库尔特香港有限公司	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 Hong Kong Limited 贝克曼库尔特香港有限公司	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 Hong Kong Limited 贝克曼库尔特香港有限公司	Aug 08, 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 Hong Kong Limited 贝克曼库尔特香港有限公司	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 Hong Kong Limited 贝克曼库尔特香港有限公司	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 Hong Kong Limited 贝克曼库尔特香港有限公司	Jul 24, 2024
IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D 体外诊断测试试剂/试剂盒、免疫测定、维生素、D 代谢物、25-羟基维生素 D	B	Beckman Coulter Hong Kong Limited 贝克曼库尔特香港有限公司	Jul 24, 2024
IVD Test Reagent/Kits, Immunoassay, Anemia Test, Ferritin 体外诊断测试试剂/试剂盒、免疫测定、贫血测试、铁蛋白	B	Beckman Coulter Hong Kong Limited 贝克曼库尔特香港有限公司	Mar 07, 2024

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Risk Class Breakdown

B19

Timeline

First Registration

Nov 18, 2020

Most Recent

Sep 24, 2024