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Registrant profile

Guangzhou Wondfo BIOTECH Co., Ltd.

广州万孚生物技术股份有限公司
Guangdong·China NMPA·365 registered devices
365
Total devices
2
Device classes
2015
Earliest approval
2025
Latest approval
Company overview
Total devices
365
Province/Region
Guangdong
广东
Address
No. 8, Lizhishan Road, Science City, Luogang District, Guangzhou
广州市萝岗区科学城荔枝山路8号
Registration timeline
Earliest approval
Sep 15, 2015
Latest approval
Jan 10, 2025
Device class distribution
Breakdown of 365 devices by regulatory classification
Class II
297
81.4% of total
Class III
68
18.6% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
甲型肝炎病毒IgM抗体检测试剂（免疫层析法）
Class III国械注准20253400092Jan 10, 2025Jan 09, 2030View
Progesterone detection reagent kit (chemiluminescence immunoassay method)
孕酮测定试剂盒（化学发光免疫分析法）
Class II粤械注准20252400018Jan 06, 2025Jan 05, 2030View
Estradiol determination reagent kit (chemiluminescence immunoassay)
雌二醇测定试剂盒（化学发光免疫分析法）
Class II粤械注准20252400019Jan 06, 2025Jan 05, 2030View
Serum Amyloid A (SAA) Quality Control
血清淀粉样蛋白A（SAA）质控品
Class II粤械注准20242401690Dec 19, 2024Dec 18, 2029View
血清淀粉样蛋白A(SAA)/C反应蛋白(CRP)复合质控品
血清淀粉样蛋白A（SAA）/C反应蛋白（CRP）复合质控品
Class II粤械注准20242401689Dec 19, 2024Dec 18, 2029View
C-reactive Protein (CRP) Quality Control Material
C反应蛋白（CRP）质控品
Class II粤械注准20242401691Dec 19, 2024Dec 18, 2029View
B-type Natriuretic Peptide (BNP) Quality Control
B型钠尿肽（BNP）质控品
Class II粤械注准20242401696Dec 19, 2024Dec 18, 2029View
Testosterone assay kit (chemiluminescent immunoassay method)
睾酮测定试剂盒（化学发光免疫分析法）
Class II粤械注准20242401619Dec 05, 2024Dec 04, 2029View
D-dimer (D-Dimer) controls
D-二聚体（D-Dimer）质控品
Class II粤械注准20242401605Dec 02, 2024Dec 01, 2029View
Interleukin-6 (IL-6) Quality Control
白介素-6（IL-6）质控品
Class II粤械注准20242401606Dec 02, 2024Dec 01, 2029View
About this profile

Complete regulatory portfolio for Guangzhou Wondfo BIOTECH Co., Ltd. in China's medical device market. This registrant has 365 medical devices registered with China NMPA, with registrations dating from Sep 15, 2015 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.