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Shandong Kanghua Biotechnology Co., Ltd.

山东康华生物医疗科技股份有限公司

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.

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NMPA Official Data
195 Devices
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
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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20252400040
Jan 23, 2025
Jan 22, 2030
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20253400193
Jan 20, 2025
Jan 19, 2030
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20253400108
Jan 10, 2025
Jan 09, 2030
Myocardial marker composite quality control product
心肌标志物复合质控品
Class II
鲁械注准20252400012
Jan 03, 2025
Jan 02, 2030
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20243402639
Dec 23, 2024
Dec 22, 2029
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20242401108
Dec 19, 2024
Dec 18, 2029
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20243402496
Dec 13, 2024
Dec 12, 2029
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20243402460
Dec 05, 2024
Dec 04, 2029
Fully automatic chemiluminescence immunoassay analyzer
全自动化学发光免疫分析仪
Class II
鲁械注准20242220894
Sep 30, 2024
Sep 29, 2029
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20242400770
Jul 29, 2024
Jul 28, 2029