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Registrant profile

Acon Biotech (Hangzhou) Co., Ltd.

艾康生物技术（杭州）有限公司
chekiang·China NMPA·166 registered devices
166
Total devices
2
Device classes
2015
Earliest approval
2024
Latest approval
Company overview
Total devices
166
Province/Region
chekiang
浙江
Address
No. 210, Zhenzhong Road, West Lake District, Hangzhou
杭州市西湖区振中路210号
Registration timeline
Earliest approval
Apr 20, 2015
Latest approval
Nov 21, 2024
Device class distribution
Breakdown of 166 devices by regulatory classification
Class II
90
54.2% of total
Class III
76
45.8% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
幽门螺杆菌IgG抗体检测试剂(乳胶法)
幽门螺杆菌IgG抗体检测试剂（乳胶法）
Class III国械注准20243402344Nov 21, 2024Nov 20, 2029View
Helicobacter pylori IgG antibody detection reagent (fluorescence immunoassay)
幽门螺杆菌IgG抗体检测试剂（荧光免疫分析法）
Class III国械注准20243400380Feb 21, 2024Feb 20, 2029View
Gastric pepsinogen (PG) II assay kit (chemiluminescent immunoassay)
胃蛋白酶原（PG）II检测试剂（化学发光免疫分析法）
Class II浙械注准20242401068Jan 19, 2024Oct 31, 2029View
胃蛋白酶原(PG)I检测试剂(化学发光免疫分析法)
胃蛋白酶原（PG）I检测试剂（化学发光免疫分析法）
Class II浙械注准20242401069Jan 19, 2024Oct 31, 2029View
CA15-3 test kit (chemiluminescence immunoassay)
癌抗原15-3（CA15-3）检测试剂（化学发光免疫分析法）
Class II浙械注准20242401067Jan 19, 2024Oct 31, 2029View
Gastrin-releasing peptide precursor (ProGRP) detection reagent (chemiluminescence immunoassay)
胃泌素释放肽前体（ProGRP）检测试剂（化学发光免疫分析法）
Class II浙械注准20242401066Jan 17, 2024Oct 31, 2029View
Cancer Antigen 72-4 (CA72-4) Detection Kit (Chemiluminescence Immunoassay Method)
癌抗原72-4（CA72-4）检测试剂（化学发光免疫分析法）
Class II浙械注准20242401051Jan 16, 2024Oct 31, 2029View
HE4 Test Kit for Human Epididymis Protein 4 (Chemiluminescence Immunoassay Method)
人附睾蛋白4（HE4）检测试剂（化学发光免疫分析法）
Class II浙械注准20242401052Jan 16, 2024Oct 31, 2029View
癌抗原242(CA242)检测试剂(化学发光免疫分析法)
癌抗原242（CA242）检测试剂（化学发光免疫分析法）
Class II浙械注准20242401053Jan 16, 2024Oct 31, 2029View
Full Range C-reactive Protein Detection Test Kit (Immunoturbidimetry Method)
全量程C-反应蛋白检测试剂盒（免疫比浊法）
Class II浙械注准20232401232Apr 24, 2023Apr 23, 2028View
About this profile

Complete regulatory portfolio for Acon Biotech (Hangzhou) Co., Ltd. in China's medical device market. This registrant has 166 medical devices registered with China NMPA, with registrations dating from Apr 20, 2015 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.