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Shanghai Kehua Bio-Engineering Co., Ltd.

上海科华生物工程股份有限公司

Complete regulatory portfolio for Shanghai Kehua Bio-Engineering Co., Ltd. in China's medical device market. This registrant has 227 medical devices registered with China NMPA, with registrations dating from Jul 14, 2017 to Dec 30, 2024.

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
227 Devices
Company Overview
Total Devices
227
Province/Region
Shanghai
上海
Address
1189 Qinzhou North Road, Xuhui District, Shanghai
上海市徐汇区钦州北路1189号
Registration Timeline
Earliest Approval
Jul 14, 2017
Latest Approval
Dec 30, 2024
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Device Class Distribution
Breakdown of 227 devices by regulatory classification
Class II
170
74.9% of total
Class III
57
25.1% of total
Registered Devices (10 most recent shown)
Click on any device for detailed registration information
Product NameClassRegistration NumberApproval DateExpiry DateDetail
Helicobacter pylori antibody detection test kit (latex immunoturbidimetric method)
幽门螺杆菌抗体检测试剂盒(胶乳免疫比浊法)
Class III
国械注准20243402655
Dec 30, 2024
Dec 29, 2029
肌酸激酶同工酶测定试剂盒(胶乳免疫比浊法)
肌酸激酶同工酶测定试剂盒(胶乳免疫比浊法)
Class II
沪械注准20242400393
Nov 14, 2024
Nov 13, 2029
Abnormal prothrombin assay kit (chemiluminescence)
异常凝血酶原测定试剂盒(化学发光法)
Class III
国械注准20243401590
Aug 23, 2024
Aug 22, 2029
Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Detection Reagent Kit (PCR-Fluorescent Probe Method)
人类免疫缺陷病毒1型(HIV-1)核酸测定试剂盒(PCR-荧光探针法)
Class III
国械注准20243401285
Jul 17, 2024
Jul 16, 2029
Trans-triiodothyronine assay kit (chemiluminescence method)
反三碘甲状腺原氨酸测定试剂盒(化学发光法)
Class II
沪械注准20242400208
Jun 26, 2024
Jun 25, 2029
Specific growth factor determination reagent kit (chemical method)
特异性生长因子测定试剂盒(化学法)
Class II
沪械注准20242400177
Jun 05, 2024
Jun 04, 2029
Hepatitis B virus core IgM antibody test kit (chemiluminescence method)
乙型肝炎病毒核心IgM抗体检测试剂盒(化学发光法)
Class III
国械注准20243400687
Apr 11, 2024
Apr 10, 2029
Hepatitis E virus IgM antibody test kit (chemiluminescence method)
戊型肝炎病毒IgM抗体检测试剂盒(化学发光法)
Class III
国械注准20243400608
Mar 28, 2024
Mar 27, 2029
亮氨酸氨基肽酶测定试剂盒(L-亮氨酰对硝基苯胺底物法)
Class II
沪械注准20242400042
Feb 04, 2024
Feb 03, 2029
Free light chain κ assay kit (immunoturbidimetry method)
轻链κ测定试剂盒(免疫比浊法)
Class II
沪械注准20232400360
Dec 26, 2023
Dec 25, 2028