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Registrant profile

Getein Biotech, Inc.

基蛋生物科技股份有限公司
Jiangsu·China NMPA·245 registered devices
245
Total devices
2
Device classes
2019
Earliest approval
2025
Latest approval
Company overview
Total devices
245
Province/Region
Jiangsu
江苏
Address
No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing
南京市六合区沿江工业开发区博富路9号
Registration timeline
Earliest approval
Jun 17, 2019
Latest approval
Jan 20, 2025
Device class distribution
Breakdown of 245 devices by regulatory classification
Class II
218
89.0% of total
Class III
27
11.0% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
乙型肝炎病毒核心抗体定量检测试剂盒（化学发光免疫分析法）
Class III国械注准20253400208Jan 20, 2025Jan 19, 2030View
异常凝血酶原检测试剂盒(化学发光免疫分析法)
异常凝血酶原检测试剂盒（化学发光免疫分析法）
Class III国械注准20243402400Nov 27, 2024Nov 26, 2029View
Influenza A/B virus and respiratory syncytial virus nucleic acid combined detection kit (fluorescence PCR method)
甲型/乙型流感病毒及呼吸道合胞病毒核酸联合检测试剂盒（荧光PCR法）
Class III国械注准20243401718Sep 10, 2024Sep 09, 2029View
Pepsinogen I/Pepsinogen II Assay Kit (Fluorescence Immunochromatography)
胃蛋白酶原I/胃蛋白酶原II测定剂盒（荧光免疫层析法）
Class II苏械注准20242401739Aug 30, 2024Aug 29, 2029View
血管紧张素Ⅰ测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242401204May 31, 2024May 30, 2029View
血管紧张素II测定试剂盒（化学发光免疫分析法）
Class II苏械注准20242401142May 23, 2024May 22, 2029View
Alpha-fetoprotein detection kit (fluorescence immunochromatography)
甲胎蛋白检测试剂盒（荧光免疫层析法）
Class III国械注准20243400590Mar 26, 2024Mar 25, 2029View
Fully automated nucleic acid amplification analyzer
全自动核酸扩增分析仪
Class III国械注准20243220377Feb 21, 2024Feb 20, 2029View
Human Papillomavirus (HPV) Nucleic Acid Detection and 16/18 Typing Kit (Fluorescent PCR)
人乳头瘤病毒（HPV）核酸检测及16/18分型试剂盒（荧光PCR法）
Class III国械注准20243400146Jan 18, 2024Jan 17, 2029View
Tissue plasminogen activator-inhibitor 1 composite detection test kit (chemiluminescence immunoassay)
组织型纤溶酶原激活剂-抑制剂1复合体检测试剂盒（化学发光免疫分析法）
Class II苏械注准20242400017Jan 05, 2024Jan 04, 2029View
About this profile

Complete regulatory portfolio for Getein Biotech, Inc. in China's medical device market. This registrant has 245 medical devices registered with China NMPA, with registrations dating from Jun 17, 2019 to Jan 20, 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.