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Registrant profile

Shanghai Kehua Bio-Engineering Co., Ltd.

上海科华生物工程股份有限公司
Shanghai·China NMPA·227 registered devices
227
Total devices
2
Device classes
2017
Earliest approval
2024
Latest approval
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
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20243402655Dec 30, 2024Dec 29, 2029View
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20242400393Nov 14, 2024Nov 13, 2029View
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20243401590Aug 23, 2024Aug 22, 2029View
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20243401285Jul 17, 2024Jul 16, 2029View
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20242400208Jun 26, 2024Jun 25, 2029View
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20242400177Jun 05, 2024Jun 04, 2029View
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20243400687Apr 11, 2024Apr 10, 2029View
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20243400608Mar 28, 2024Mar 27, 2029View
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20242400042Feb 04, 2024Feb 03, 2029View
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20232400360Dec 26, 2023Dec 25, 2028View
About this profile

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.