Pure Global
Registrant profile

Suzhou Hokapi Biomedical Engineering Co., Ltd.

苏州长光华医生物医学工程有限公司
Jiangsu·China NMPA·124 registered devices
124
Total devices
2
Device classes
2016
Earliest approval
2025
Latest approval
Company overview
Total devices
124
Province/Region
Jiangsu
江苏
Address
Room 101, No. 18 Madun Road, Suzhou High-tech Zone
苏州市高新区马墩路18号101室
Registration timeline
Earliest approval
Aug 19, 2016
Latest approval
Jan 08, 2025
Device class distribution
Breakdown of 124 devices by regulatory classification
Class II
81
65.3% of total
Class III
43
34.7% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
胃泌素-17测定试剂盒（化学发光免疫分析法）
Class II苏械注准20252400050Jan 08, 2025Jan 07, 2030View
Anti-Müllerian Hormone Test Kit (Chemiluminescence Immunoassay Method)
抗缪勒氏管激素测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242402176Nov 20, 2024Nov 19, 2029View
Fully automatic chemiluminescence immunoassay analyzer
全自动化学发光免疫分析仪
Class II苏械注准20242222098Oct 31, 2024Oct 30, 2029View
Prostate acid phosphatase detection kit (chemiluminescent immunoassay)
前列腺酸性磷酸酶测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242400402Mar 25, 2024Sep 01, 2029View
Gastric protease I detection reagent kit (chemiluminescence immunoassay method)
胃蛋白酶原I测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242400365Mar 13, 2024Sep 01, 2029View
Pepsinogen II assay kit (chemiluminescence immunoassay)
胃蛋白酶原Ⅱ测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242400335Mar 08, 2024Sep 01, 2029View
Progesterone Detection Kit (Chemiluminescent Immunoassay)
孕酮测定试剂盒(化学发光免疫分析法)
Class II苏械注准20232400731May 25, 2023May 24, 2028View
Estradiol Test Kit (Chemiluminescence Immunoassay)
雌二醇测定试剂盒(化学发光免疫分析法)
Class II苏械注准20232400707May 22, 2023May 21, 2028View
D-dimer Assay Kit (Chemiluminescence Immunoassay)
D-二聚体检测试剂盒(化学发光免疫分析法)
Class II苏械注准20232400706May 22, 2023May 21, 2028View
Fully automatic chemiluminescence immunoassay analyzer
全自动化学发光免疫分析仪
Class II苏械注准20232220064Jan 12, 2023Jul 11, 2028View
About this profile

Complete regulatory portfolio for Suzhou Hokapi Biomedical Engineering Co., Ltd. in China's medical device market. This registrant has 124 medical devices registered with China NMPA, with registrations dating from Aug 19, 2016 to Jan 08, 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.