Pure Global
Registrant profile

Xiamen Innodx BIOTECH Co., Ltd.

厦门万泰凯瑞生物技术有限公司
Fujian·China NMPA·183 registered devices
183
Total devices
2
Device classes
2017
Earliest approval
2025
Latest approval
Company overview
Total devices
183
Province/Region
Fujian
福建
Address
2nd floor, No. 124, Xinyuan Road, Xinyang Street
新阳街道新园路124号2楼
Registration timeline
Earliest approval
Jun 28, 2017
Latest approval
Jan 20, 2025
Device class distribution
Breakdown of 183 devices by regulatory classification
Class II
96
52.5% of total
Class III
87
47.5% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
Herpes simplex virus type 1 IgG antibody test kit (magnetic particle chemiluminescence method)
单纯疱疹病毒1型IgG抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20253400211Jan 20, 2025Jan 19, 2030View
Herpes Simplex Virus Type 2 IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method)
单纯疱疹病毒2型IgM抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20253400089Jan 10, 2025Jan 09, 2030View
Cytomegalovirus IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method)
巨细胞病毒IgM抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20253400077Jan 10, 2025Jan 09, 2030View
Herpes simplex virus type 1 IgM antibody detection test kit (magnetic particle chemiluminescence method)
单纯疱疹病毒1型IgM抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20253400103Jan 10, 2025Jan 09, 2030View
EB病毒BNLF2b抗体检测试剂盒(磁微粒化学发光法)
EB病毒BNLF2b抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20243402134Oct 24, 2024Oct 23, 2029View
Rubella Virus IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method)
风疹病毒IgM抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20243401942Sep 29, 2024Sep 28, 2029View
Total thyroxine (TT4) Assay Kit (Magnetic Particle Chemiluminescence Method)
总甲状腺素(TT4)测定试剂盒（磁微粒化学发光法）
Class II闽械注准20242400173Sep 20, 2024Sep 19, 2029View
Free thyroxine (FT4) detection reagent kit (magnetic particle chemiluminescence method)
游离甲状腺素(FT4)测定试剂盒（磁微粒化学发光法）
Class II闽械注准20242400174Sep 20, 2024Sep 19, 2029View
Cytomegalovirus IgG antibody test kit (magnetic microparticle chemiluminescence method)
巨细胞病毒IgG抗体检测试剂盒（磁微粒化学发光法）
Class III国械注准20243401663Sep 02, 2024Sep 01, 2029View
Rubella Virus IgG Antibody Assay Kit (Magnetic Particle Chemiluminescence Method)
风疹病毒IgG抗体测定试剂盒（磁微粒化学发光法）
Class III国械注准20243401310Jul 23, 2024Jul 22, 2029View
About this profile

Complete regulatory portfolio for Xiamen Innodx BIOTECH Co., Ltd. in China's medical device market. This registrant has 183 medical devices registered with China NMPA, with registrations dating from Jun 28, 2017 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.