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Registrant profile

Aikang Diagnostics Co., Ltd.

深圳市爱康试剂有限公司
Guangdong·China NMPA·138 registered devices
138
Total devices
2
Device classes
2020
Earliest approval
2025
Latest approval
Company overview
Total devices
138
Province/Region
Guangdong
广东
Address
Plant 501, No. 3, Hongxin Industrial Park, No. 1303, Xinlan Community Tourism Road, Guanlan Street, Longhua District, Shenzhen; Plant 1, Building 501
深圳市龙华区观澜街道新澜社区观光路1303号鸿信工业园3号厂房501；1号厂房501
Registration timeline
Earliest approval
Jul 22, 2020
Latest approval
Jan 10, 2025
Device class distribution
Breakdown of 138 devices by regulatory classification
Class II
109
79.0% of total
Class III
29
21.0% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
Treponema pallidum antibody detection reagent kit (chemiluminescent immunoassay)
梅毒螺旋体抗体检测试剂盒（化学发光免疫分析法）
Class III国械注准20253400094Jan 10, 2025Jan 09, 2030View
丙氨酸氨基转移酶/血红蛋白联检试剂盒（干化学法）
Class II粤械注准20252400011Jan 06, 2025Jan 05, 2030View
Human Irregular Antibody Screening Red Blood Cell Kit
人不规则抗体筛选红细胞试剂盒
Class III国械注准20243401431Aug 05, 2024Aug 04, 2029View
ABO Forward and Reverse Typing and RhD Blood Type Test Card (Microcolumn Gel Method)
ABO正反定型及RhD血型检测卡（微柱凝胶法）
Class III国械注准20243400889May 09, 2024May 08, 2029View
Hepatitis C Virus Antibody Test Kit (Chemiluminescence Immunoassay)
丙型肝炎病毒抗体检测试剂盒（化学发光免疫分析法）
Class III国械注准20243400765Apr 26, 2024Apr 25, 2029View
Hepatitis B virus surface antigen determination reagent kit (chemiluminescence immunoassay method)
乙型肝炎病毒表面抗原测定试剂盒（化学发光免疫分析法）
Class III国械注准20243400760Apr 24, 2024Apr 23, 2029View
D-dimer (D-Dimer) Assay Kit (Chemiluminescence Method)
D－二聚体（D-Dimer）测定试剂盒(化学发光法)
Class II粤械注准20242400424Mar 26, 2024Mar 25, 2029View
Hepatitis B virus surface antigen test kit (colloidal gold method)
乙型肝炎病毒表面抗原检测试剂盒（胶体金法）
Class III国械注准20243400578Mar 21, 2024Mar 20, 2029View
Treponema pallidum Antibody Test Kit (Colloidal Gold Method)
梅毒螺旋体抗体检测试剂盒（胶体金法）
Class III国械注准20243400580Mar 21, 2024Mar 20, 2029View
N-terminal brain natriuretic peptide precursor (NT-proBNP) assay kit (chemiluminescence method)
N 端脑利钠肽前体（NT-proBNP）测定试剂盒(化学发光法)
Class II粤械注准20242400382Mar 13, 2024Mar 12, 2029View
About this profile

Complete regulatory portfolio for Aikang Diagnostics Co., Ltd. in China's medical device market. This registrant has 138 medical devices registered with China NMPA, with registrations dating from Jul 22, 2020 to Jan 10, 2025.

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.