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Biobase Biodustry (Shandong) Co., Ltd.

山东博科生物产业有限公司

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.

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NMPA Official Data
148 Devices
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
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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20232401176
Dec 20, 2023
Dec 19, 2028
Fully automated specific protein analyzer
全自动特定蛋白分析仪
Class II
鲁械注准20232220890
Sep 17, 2023
Sep 16, 2028
Immunofive Composite Calibration Solution
免疫五项复合校准品
Class II
鲁械注准20232400830
Aug 28, 2023
Aug 27, 2028
5. Classification of blood cell analyzers
五分类血细胞分析仪
Class II
鲁械注准20232220518
Jun 26, 2023
Jun 16, 2028
Blood cell analyzer
血细胞分析仪
Class II
鲁械注准20232220455
Jun 16, 2023
May 28, 2028
Special protein composite quality control product
特种蛋白复合质控品
Class II
鲁械注准20222401339
Nov 24, 2022
Nov 23, 2027
Blood lipid class composite quality control product
血脂类复合质控品
Class II
鲁械注准20222401338
Nov 24, 2022
Nov 23, 2027
Electrolyte analyzer
电解质分析仪
Class II
鲁械注准20222221121
Sep 13, 2022
Sep 12, 2027
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20222401101
Sep 06, 2022
Sep 05, 2027
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20162400026
Aug 04, 2022
Dec 17, 2025