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Registrant profile

Biobase Biodustry (Shandong) Co., Ltd.

山东博科生物产业有限公司
Shandong·China NMPA·148 registered devices
148
Total devices
2
Device classes
2017
Earliest approval
2023
Latest approval
Company overview
Total devices
148
Province/Region
Shandong
山东
Address
Minshui Economic Development Zone, Zhangqiu District, Jinan City, Shandong Province (Shandong Brocade Industrial Park, junction of Shidong Road and Mingbu Road)
山东省济南市章丘区明水经济开发区（经十东路与明埠路交界山东博科产业园）
Registration timeline
Earliest approval
Feb 07, 2017
Latest approval
Dec 20, 2023
Device class distribution
Breakdown of 148 devices by regulatory classification
Class II
137
92.6% of total
Class III
11
7.4% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
Full-scale C-reactive protein (hs-CRP+ conventional CRP) assay kit (latex immunoturbidimetry)
全量程C反应蛋白（hs-CRP+常规CRP）测定试剂盒（胶乳免疫比浊法）
Class II鲁械注准20232401176Dec 20, 2023Dec 19, 2028View
Fully automated specific protein analyzer
全自动特定蛋白分析仪
Class II鲁械注准20232220890Sep 17, 2023Sep 16, 2028View
Immunofive Composite Calibration Solution
免疫五项复合校准品
Class II鲁械注准20232400830Aug 28, 2023Aug 27, 2028View
5. Classification of blood cell analyzers
五分类血细胞分析仪
Class II鲁械注准20232220518Jun 26, 2023Jun 16, 2028View
Blood cell analyzer
血细胞分析仪
Class II鲁械注准20232220455Jun 16, 2023May 28, 2028View
Special protein composite quality control product
特种蛋白复合质控品
Class II鲁械注准20222401339Nov 24, 2022Nov 23, 2027View
Blood lipid class composite quality control product
血脂类复合质控品
Class II鲁械注准20222401338Nov 24, 2022Nov 23, 2027View
Electrolyte analyzer
电解质分析仪
Class II鲁械注准20222221121Sep 13, 2022Sep 12, 2027View
Sodium, potassium, chloride electrolyte detection reagent kit (ion selective electrode method)
钠、钾、氯电解质检测试剂盒（离子选择电极法）
Class II鲁械注准20222401101Sep 06, 2022Sep 05, 2027View
Retinol-binding protein assay kit (immune turbidimetry)
视黄醇结合蛋白检测试剂盒（免疫比浊法）
Class II鲁械注准20162400026Aug 04, 2022Dec 17, 2025View
About this profile

Complete regulatory portfolio for Biobase Biodustry (Shandong) Co., Ltd. in China's medical device market. This registrant has 148 medical devices registered with China NMPA, with registrations dating from Feb 07, 2017 to Dec 20, 2023.

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.