Applicant profileBeckman Coulter, Inc.
Beckman Coulter, Inc.
Hong Kong MDACSUnited States32 registered devicesNov 18, 2020 – Sep 24, 2024
VerifiedMDD (Medical Device Division) · MDACS registry
32
Total devices
3
Risk classes
2020
First registration
2024
Most recent
Applicant overview
- Applicant (EN)
- Beckman Coulter, Inc.
- Applicant (ZH)
- Beckman Coulter, Inc.
- Country
- United States
- Address
- 250 South Kraemer Blvd., Brea, California, 92821, USA
美国
250南克雷默大道,布雷亚,加利福尼亚州,92821,美国
Timeline
- First registration
- Nov 18, 2020
- Most recent
- Sep 24, 2024
Regulatory footprint
Search Beckman Coulter, Inc. across other regulatory registries
Thailand
European Union
Colombia
South Korea
Canada
EcuadorRisk class breakdown
B19
C9
D4
Recent MDACS registrations
Latest 15 devices linked to this applicant
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
Sep 24, 2024
- Risk class
- C
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Sep 24, 2024
- Risk class
- C
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Sep 24, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Sep 24, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Sep 24, 2024
- Risk class
- C
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Aug 08, 2024
- Risk class
- C
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Aug 08, 2024
- Risk class
- C
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Aug 08, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Aug 08, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Aug 08, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Jul 24, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Jul 24, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Jul 24, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Jul 24, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
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
Mar 07, 2024
- Risk class
- B
- Authorised rep
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
About this profile
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.