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Acon Biotech (Hangzhou) Co., Ltd.

艾康生物技术(杭州)有限公司

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.

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NMPA Official Data
166 Devices
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
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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20243402344
Nov 21, 2024
Nov 20, 2029
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20243400380
Feb 21, 2024
Feb 20, 2029
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20242401068
Jan 19, 2024
Oct 31, 2029
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20242401069
Jan 19, 2024
Oct 31, 2029
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20242401067
Jan 19, 2024
Oct 31, 2029
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20242401066
Jan 17, 2024
Oct 31, 2029
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20242401051
Jan 16, 2024
Oct 31, 2029
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20242401052
Jan 16, 2024
Oct 31, 2029
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20242401053
Jan 16, 2024
Oct 31, 2029
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20232401232
Apr 24, 2023
Apr 23, 2028