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Registrant profile

Beijing BGI-GBI Biotech Co., Ltd.

北京华大吉比爱生物技术有限公司
Beijing·China NMPA·146 registered devices
146
Total devices
2
Device classes
2017
Earliest approval
2024
Latest approval
Company overview
Total devices
146
Province/Region
Beijing
北京
Address
Room 236, Room 237, Building 1, No. 538, Yongfeng Tun, Haidian District, Beijing
北京市海淀区永丰屯538号1号楼236、237室
Registration timeline
Earliest approval
Apr 10, 2017
Latest approval
Nov 21, 2024
Device class distribution
Breakdown of 146 devices by regulatory classification
Class II
81
55.5% of total
Class III
65
44.5% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
Hepatitis E Virus IgM Antibody Test Kit (Magnetic Microparticle Chemiluminescence Method)
戊型肝炎病毒IgM抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20243402356Nov 21, 2024Nov 20, 2029View
Mycobacterium tuberculosis-specific cell-mediated immune response detection kit (chemiluminescence method with magnetic microspheres)
结核分枝杆菌特异性细胞免疫反应检测试剂盒（磁微粒化学发光法）
Class III国械注准20243401207Jul 02, 2024Jul 01, 2029View
Human Immunodeficiency Virus Antigen/Antibody Assay Kit (Magnetic Particle Chemiluminescence Method)
人类免疫缺陷病毒抗原/抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20243400577Mar 21, 2024Mar 20, 2029View
Hepatitis B Virus Pre-S1 Antigen Test Kit (Chemiluminescence Magnetic Microparticle Method)
乙型肝炎病毒前S1抗原检测试剂盒（磁微粒化学发光法）
Class III国械注准20243400501Mar 13, 2024Mar 12, 2029View
Hepatitis B virus pre-S2 antigen detection kit (magnetic particle chemiluminescence method)
乙型肝炎病毒前S2抗原检测试剂盒（磁微粒化学发光法）
Class III国械注准20243400455Mar 08, 2024Mar 07, 2029View
Hepatitis B virus core antibody IgM detection test kit (magnetic particle chemiluminescence)
乙型肝炎病毒核心抗体IgM检测试剂盒（磁微粒化学发光法）
Class III国械注准20243400447Mar 05, 2024Mar 04, 2029View
Hepatitis E virus IgG antibody detection reagent kit (magnetic particle chemiluminescence assay)
戊型肝炎病毒IgG抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20243400445Mar 05, 2024Mar 04, 2029View
Catecholamines and their metabolite controls
儿茶酚胺及其代谢物质控品
Class II京械注准20232400014Jan 04, 2023Jan 03, 2028View
Catecholamines and their metabolite calibracents
儿茶酚胺及其代谢物校准品
Class II京械注准20232400012Jan 04, 2023Jan 03, 2028View
Catecholamines and their metabolite controls
儿茶酚胺及其代谢物质控品
Class II京械注准20232400015Jan 04, 2023Jan 03, 2028View
About this profile

Complete regulatory portfolio for Beijing BGI-GBI Biotech Co., Ltd. in China's medical device market. This registrant has 146 medical devices registered with China NMPA, with registrations dating from Apr 10, 2017 to Nov 21, 2024.

Browse the complete device portfolio including device classifications, registration numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive China NMPA registration data, helping global MedTech companies analyze market presence and regulatory compliance for Chinese medical device manufacturers.