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Registrant profile

Guangzhou Kangrun Biotechnology Co., Ltd.

广州市康润生物科技有限公司
Guangdong·China NMPA·175 registered devices
175
Total devices
2
Device classes
2020
Earliest approval
2025
Latest approval
Company overview
Total devices
175
Province/Region
Guangdong
广东
Address
No. 6 Nanjiang 2nd Road, Zhujiang Street, Nansha District, Guangzhou, 9 buildings (6# building) 13 floors
广州市南沙区珠江街南江二路6号自编9栋（6#楼）13层
Registration timeline
Earliest approval
Jan 17, 2020
Latest approval
Jan 20, 2025
Device class distribution
Breakdown of 175 devices by regulatory classification
Class II
161
92.0% of total
Class III
14
8.0% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
I型单纯疱疹病毒IgM抗体（HSV-I IgM）检测试剂盒（化学发光免疫分析法）
Class III国械注准20253400215Jan 20, 2025Jan 19, 2030View
风疹病毒IgM抗体（Rub IgM）检测试剂盒（化学发光免疫分析法）
Class III国械注准20253400206Jan 20, 2025Jan 19, 2030View
弓形虫IgM抗体（Toxo IgM）检测试剂盒（化学发光免疫分析法）
Class III国械注准20253400198Jan 20, 2025Jan 19, 2030View
II型单纯疱疹病毒IgM抗体（HSV-II IgM）检测试剂盒（化学发光免疫分析法）
Class III国械注准20253400098Jan 10, 2025Jan 09, 2030View
D-dimer detection reagent kit (magnetic particle chemiluminescence)
D-二聚体（D-Dimer）测定试剂盒（磁微粒化学发光法）
Class II粤械注准20252400020Jan 06, 2025Jan 05, 2030View
Autoantibody Spectrum IgG Assay Kit (Indirect Immunofluorescence Method)
自身抗体谱IgG检测试剂盒(间接免疫荧光法)
Class II粤械注准20242401773Dec 27, 2024Dec 26, 2029View
肾素(Renin)测定试剂盒(磁微粒化学发光法)
肾素（Renin）测定试剂盒(磁微粒化学发光法)
Class II粤械注准20242401698Dec 19, 2024Dec 18, 2029View
髓过氧化物酶(MPO)测定试剂盒(磁微粒化学发光法)
髓过氧化物酶（MPO）测定试剂盒(磁微粒化学发光法)
Class II粤械注准20242401678Dec 17, 2024Dec 16, 2029View
醛固酮(ALD)测定试剂盒(磁微粒化学发光法)
醛固酮（ALD）测定试剂盒(磁微粒化学发光法)
Class II粤械注准20242401662Dec 10, 2024Dec 09, 2029View
Creatine Kinase-MB (CK-MB) Assay Kit (Chemiluminescence Method with Magnetic Microparticles)
肌酸激酶同工酶（CK-MB）测定试剂盒(磁微粒化学发光法)
Class II粤械注准20242401598Nov 29, 2024Nov 28, 2029View
About this profile

Complete regulatory portfolio for Guangzhou Kangrun Biotechnology Co., Ltd. in China's medical device market. This registrant has 175 medical devices registered with China NMPA, with registrations dating from Jan 17, 2020 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.