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Registrant profile

Shandong Kanghua Biotechnology Co., Ltd.

山东康华生物医疗科技股份有限公司
Shandong·China NMPA·195 registered devices
195
Total devices
2
Device classes
2019
Earliest approval
2025
Latest approval
Company overview
Total devices
195
Province/Region
Shandong
山东
Address
No. 699, Yuehe Road, Weifang Economic Development Zone
潍坊经济开发区月河路699号
Registration timeline
Earliest approval
Apr 04, 2019
Latest approval
Jan 23, 2025
Device class distribution
Breakdown of 195 devices by regulatory classification
Class II
113
57.9% of total
Class III
82
42.1% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
Composite quality control material for heart failure markers
心衰标志物复合质控品
Class II鲁械注准20252400040Jan 23, 2025Jan 22, 2030View
肺炎衣原体IgG抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20253400193Jan 20, 2025Jan 19, 2030View
Mycoplasma pneumoniae IgM antibody detection test kit (magnetic microparticle chemiluminescence method)
肺炎衣原体IgM抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20253400108Jan 10, 2025Jan 09, 2030View
Myocardial marker composite quality control product
心肌标志物复合质控品
Class II鲁械注准20252400012Jan 03, 2025Jan 02, 2030View
Hepatitis B virus surface antigen test kit (magnetic particle chemiluminescence method)
乙型肝炎病毒表面抗原检测试剂盒（磁微粒化学发光法）
Class III国械注准20243402639Dec 23, 2024Dec 22, 2029View
Fibrinogen (FIB) detection test kit (coagulation method)
纤维蛋白原（FIB）检测试剂盒（凝固法）
Class II鲁械注准20242401108Dec 19, 2024Dec 18, 2029View
Mycoplasma Pneumoniae IgG Antibody Test Kit (Magnetic Microparticle Chemiluminescence)
肺炎支原体IgG抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20243402496Dec 13, 2024Dec 12, 2029View
IgM Antibody Test Kit for Mycoplasma Pneumoniae (Chemiluminescent Magnetic Particle Method)
肺炎支原体IgM抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20243402460Dec 05, 2024Dec 04, 2029View
Fully automatic chemiluminescence immunoassay analyzer
全自动化学发光免疫分析仪
Class II鲁械注准20242220894Sep 30, 2024Sep 29, 2029View
Lipoprotein-associated phospholipase A2 assay kit (chemiluminescence magnetic particle method)
脂蛋白相关磷脂酶A2测定试剂盒（磁微粒化学发光法）
Class II鲁械注准20242400770Jul 29, 2024Jul 28, 2029View
About this profile

Complete regulatory portfolio for Shandong Kanghua Biotechnology Co., Ltd. in China's medical device market. This registrant has 195 medical devices registered with China NMPA, with registrations dating from Apr 04, 2019 to Jan 23, 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.