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Legacy registrant archive

Shandong Kanghua Biotechnology Co., Ltd.

山东康华生物医疗科技股份有限公司
ShandongChina NMPA195 archived records
Static archiveNMPA · legacy registration snapshot
195
Archived records
2
Device classes
2019
Earliest approval
2025
Latest approval
Company overview
Archived records
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
Regulatory footprint
Search Shandong Kanghua Biotechnology Co., Ltd. across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Device class distribution
Breakdown of 195 devices by regulatory classification
Class II11357.9% of total
Class III8242.1% of total
Archived records (10 most recent shown)
Click on any device for detailed registration information
Composite quality control material for heart failure markers
心衰标志物复合质控品
Jan 23, 2025
Registration number
鲁械注准20252400040
Class
Class II
Expiry date
Jan 22, 2030
肺炎衣原体IgG抗体检测试剂盒（磁微粒化学发光法）
Jan 20, 2025
Registration number
国械注准20253400193
Class
Class III
Expiry date
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）
Jan 10, 2025
Registration number
国械注准20253400108
Class
Class III
Expiry date
Jan 09, 2030
Myocardial marker composite quality control product
心肌标志物复合质控品
Jan 03, 2025
Registration number
鲁械注准20252400012
Class
Class II
Expiry date
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）
Dec 23, 2024
Registration number
国械注准20243402639
Class
Class III
Expiry date
Dec 22, 2029
Fibrinogen (FIB) detection test kit (coagulation method)
纤维蛋白原（FIB）检测试剂盒（凝固法）
Dec 19, 2024
Registration number
鲁械注准20242401108
Class
Class II
Expiry date
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）
Dec 13, 2024
Registration number
国械注准20243402496
Class
Class III
Expiry date
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）
Dec 05, 2024
Registration number
国械注准20243402460
Class
Class III
Expiry date
Dec 04, 2029
Fully automatic chemiluminescence immunoassay analyzer
全自动化学发光免疫分析仪
Sep 30, 2024
Registration number
鲁械注准20242220894
Class
Class II
Expiry date
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）
Jul 29, 2024
Registration number
鲁械注准20242400770
Class
Class II
Expiry date
Jul 28, 2029
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About this profile

This static archive contains 195 records under the historical name Shandong Kanghua Biotechnology 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.