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Registrant profile

Beijing Leadman Biochemistry Co., Ltd.

北京利德曼生化股份有限公司
Beijing·China NMPA·275 registered devices
275
Total devices
2
Device classes
2015
Earliest approval
2024
Latest approval
Company overview
Total devices
275
Province/Region
Beijing
北京
Address
No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
北京市北京经济技术开发区兴海路5号
Registration timeline
Earliest approval
Nov 19, 2015
Latest approval
Nov 26, 2024
Device class distribution
Breakdown of 275 devices by regulatory classification
Class II
242
88.0% of total
Class III
33
12.0% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
Acid phosphatase assay kit (α-naphthol phosphate method)
酸性磷酸酶测定试剂盒（α-磷酸萘酚底物法）
Class II京械注准20242400733Nov 26, 2024Nov 25, 2029View
总铁结合力(TIBC)校准品
总铁结合力（TIBC）校准品
Class II京械注准20242400629Nov 08, 2024Nov 07, 2029View
Carbohydrate antigen CA19-9 assay kit (chemiluminescence method with magnetic microspheres)
糖类抗原CA19-9测定试剂盒（磁微粒化学发光法）
Class II京械注准20242400302Jun 06, 2024Jun 05, 2029View
Fully automatic chemiluminescence immunoassay analyzer
全自动化学发光免疫分析仪
Class II京械注准20232220439Jul 03, 2023Jul 02, 2028View
5'-Nucleotidase (5'-NT) Test Kit (Peroxidase Method)
5'-核苷酸酶（5'-NT）测定试剂盒(过氧化物酶法)
Class II京械注准20232400385Jun 20, 2023Jun 19, 2028View
Leucine aminopeptidase (LAP) detection kit (L-leucine-p-nitroaniline substrate method)
亮氨酸氨基转肽酶（LAP）测定试剂盒 （L－亮氨酸-p-硝基苯胺底物法）
Class II京械注准20232400386Jun 20, 2023Jun 19, 2028View
B Factor (BF) Assay Kit (Immune Turbidimetric Method)
B因子（BF）测定试剂盒（免疫比浊法）
Class II京械注准20232400329May 15, 2023May 14, 2028View
Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Reagent Kit (Latex Immunoturbidimetric Method)
脂蛋白磷脂酶A2（Lp-PLA2）测定试剂盒 (胶乳免疫比浊法)
Class II京械注准20232400328May 15, 2023May 14, 2028View
Ceruloplasmin quality control material
铜蓝蛋白质控品
Class III国械注准20223401234Sep 09, 2022Sep 08, 2027View
Hepatitis B virus e antibody (HBeAb) assay kit (Chemiluminescent magnetic particle method)
乙型肝炎病毒e抗体（HBeAb）测定试剂盒（磁微粒化学发光法）
Class III国械注准20173401374Jul 18, 2022Aug 29, 2027View
About this profile

Complete regulatory portfolio for Beijing Leadman Biochemistry Co., Ltd. in China's medical device market. This registrant has 275 medical devices registered with China NMPA, with registrations dating from Nov 19, 2015 to Nov 26, 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.