Pure Global
Registrant profile

Weifang Kanghua Biotechnology Co., Ltd

潍坊市康华生物技术有限公司
Shandong·China NMPA·143 registered devices
143
Total devices
2
Device classes
2015
Earliest approval
2022
Latest approval
Company overview
Total devices
143
Province/Region
Shandong
山东
Address
No. 699, Yuehe Road, Weifang Economic Development Zone
潍坊市经济开发区月河路699号
Registration timeline
Earliest approval
Jun 08, 2015
Latest approval
Apr 06, 2022
Device class distribution
Breakdown of 143 devices by regulatory classification
Class II
123
86.0% of total
Class III
20
14.0% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
Influenza B virus IgM antibody detection kit (colloidal gold method)
B型流感病毒IgM抗体检测试剂盒（胶体金法）
Class III国械注准20223400463Apr 06, 2022Apr 05, 2027View
Prostate Specific Antigen Test Kit (Magnetic Microparticle Chemiluminescence Method)
前列腺特异性抗原检测试剂盒（磁微粒化学发光法）
Class III国械注准20213400088Feb 03, 2021Feb 02, 2026View
Free Prostate Specific Antigen (fPSA) Detection Kit (Magnetic Microparticle Chemiluminescence Method)
游离前列腺特异性抗原检测试剂盒（磁微粒化学发光法）
Class III国械注准20213400068Jan 26, 2021Jan 25, 2026View
Troponin I (cTnI) assay kit (magnetic particle chemiluminescence method)
肌钙蛋白I(cTnI)测定试剂盒（磁微粒化学发光法）
Class II鲁械注准20202401155Nov 07, 2020Nov 06, 2025View
Sperm Antibody Detection Test Kit (Enzyme-linked Immunosorbent Assay)
抗精子抗体检测试剂（酶联免疫法）
Class II鲁械注准20152400612Oct 27, 2020Oct 26, 2025View
Anti-endometrial antibody detection kit (enzyme-linked immunosorbent assay)
抗子宫内膜抗体检测试剂（酶联免疫法）
Class II鲁械注准20152400613Oct 27, 2020Oct 26, 2025View
γ-Glutamyltransferase Assay Kit (GCANA Substrate Method)
γ-谷氨酰基转移酶测定试剂盒（GCANA底物法）
Class II鲁械注准20152400621Oct 27, 2020Oct 26, 2025View
Creatine Kinase Isoenzyme (CK-MB) Detection Reagent Kit (Chemiluminescence Immunoassay)
肌酸激酶同工酶（CK-MB）测定试剂盒（磁微粒化学发光法）
Class II鲁械注准20202400848Aug 12, 2020Aug 11, 2025View
Myeloperoxidase (MPO) detection kit (magnetic particle chemiluminescence method)
髓过氧化物酶（MPO）测定试剂盒（磁微粒化学发光法）
Class II鲁械注准20202400835Aug 07, 2020Aug 06, 2025View
Free Triiodothyronine Test Kit (Chemiluminescence Method)
游离三碘甲状腺原氨酸检测试剂盒（化学发光法）
Class II鲁械注准20152400645Jul 30, 2020Jul 29, 2025View
About this profile

Complete regulatory portfolio for Weifang Kanghua Biotechnology Co., Ltd in China's medical device market. This registrant has 143 medical devices registered with China NMPA, with registrations dating from Jun 08, 2015 to Apr 06, 2022.

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.