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Registrant profile

Zhuhai Livzon Diagnostics INC.

珠海丽珠试剂股份有限公司
Guangdong·China NMPA·153 registered devices
153
Total devices
2
Device classes
2016
Earliest approval
2025
Latest approval
Company overview
Total devices
153
Province/Region
Guangdong
广东
Address
Building 1, No. 266, Tongchang Road, Xiangzhou District, Zhuhai
珠海市香洲区同昌路266号1栋
Registration timeline
Earliest approval
Dec 29, 2016
Latest approval
Jan 10, 2025
Device class distribution
Breakdown of 153 devices by regulatory classification
Class II
102
66.7% of total
Class III
51
33.3% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
新型冠状病毒（2019-nCoV）、甲型流感病毒、乙型流感病毒核酸检测试剂盒（PCR-荧光探针法）
Class III国械注准20253400082Jan 10, 2025Jan 09, 2030View
Chlamydia Pneumoniae IgG Antibody Test Kit (Colloidal Gold Method)
肺炎衣原体IgG抗体检测试剂盒（胶体金法）
Class III国械注准20243402654Dec 30, 2024Dec 29, 2029View
抗β2糖蛋白1结构域1抗体IgG测定试剂盒(化学发光法)
抗β2糖蛋白1结构域1抗体IgG测定试剂盒（化学发光法）
Class II粤械注准20242401661Dec 10, 2024Dec 09, 2029View
抗β2糖蛋白1结构域1抗体IgG质控品
Class II粤械注准20242401614Dec 05, 2024Dec 04, 2029View
Anti-cyclic citrullinated peptide antibody assay kit (chemiluminescence method)
抗环瓜氨酸肽抗体测定试剂盒（化学发光法）
Class II粤械注准20242401494Nov 06, 2024Nov 05, 2029View
类风湿关节炎相关自身抗体3项检测试剂盒(磁条码免疫荧光发光法)
类风湿关节炎相关自身抗体3项检测试剂盒（磁条码免疫荧光发光法）
Class II粤械注准20242401372Oct 16, 2024Oct 15, 2029View
抗突变型瓜氨酸化波形蛋白抗体IgG质控品
Class II粤械注准20242401383Oct 16, 2024Oct 15, 2029View
Anti-C1q antibody IgG control
抗C1q抗体IgG质控品
Class II粤械注准20242401355Oct 14, 2024Oct 13, 2029View
Anti-C1q antibody IgG assay kit (chemiluminescence method)
抗C1q抗体IgG测定试剂盒（化学发光法）
Class II粤械注准20242401360Oct 14, 2024Oct 13, 2029View
Mycoplasma pneumoniae IgG Antibody Test Kit (chemiluminescence)
肺炎支原体IgG抗体检测试剂盒（化学发光法）
Class III国械注准20243401729Sep 12, 2024Sep 11, 2029View
About this profile

Complete regulatory portfolio for Zhuhai Livzon Diagnostics INC. in China's medical device market. This registrant has 153 medical devices registered with China NMPA, with registrations dating from Dec 29, 2016 to Jan 10, 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.