Legacy registrant archive

Acon Biotech (Hangzhou) Co., Ltd.

艾康生物技术（杭州）有限公司

chekiangChina NMPA166 archived records

Static archiveNMPA · legacy registration snapshot

166

Archived records

2

Device classes

2015

Earliest approval

2024

Latest approval

Company overview

Archived records: 166
Province/Region: chekiang
Address: No. 210, Zhenzhong Road, West Lake District, Hangzhou

Registration timeline

Earliest approval: Apr 20, 2015
Latest approval: Nov 21, 2024

Regulatory footprint

Search Acon Biotech (Hangzhou) Co., Ltd. across other regulatory registries

Device class distribution

Breakdown of 166 devices by regulatory classification

Class II9054.2% of total

Class III7645.8% of total

Archived records (10 most recent shown)

Click on any device for detailed registration information

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）

Registration number: 国械注准20243402344
Class: Class III
Expiry date: 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）

Registration number: 国械注准20243400380
Class: Class III
Expiry date: 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）

Registration number: 浙械注准20242401068
Class: Class II
Expiry date: 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）

Registration number: 浙械注准20242401069
Class: Class II
Expiry date: 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）

Registration number: 浙械注准20242401067
Class: Class II
Expiry date: 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）

Registration number: 浙械注准20242401066
Class: Class II
Expiry date: 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）

Registration number: 浙械注准20242401051
Class: Class II
Expiry date: 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）

Registration number: 浙械注准20242401052
Class: Class II
Expiry date: 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）

Registration number: 浙械注准20242401053
Class: Class II
Expiry date: 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）

Registration number: 浙械注准20232401232
Class: Class II
Expiry date: Apr 23, 2028

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About this profile

This static archive contains 166 records under the historical name Acon Biotech (Hangzhou) Co., Ltd.. It does not establish the company's complete current portfolio or current authorization status.

Historical English translations and official Chinese names can differ. These archived names are not automatically equated with a holder in the current domestic-registration listing.