Legacy registrant archive

Guangzhou Wondfo BIOTECH Co., Ltd.

广州万孚生物技术股份有限公司

GuangdongChina NMPA365 archived records

Static archiveNMPA · legacy registration snapshot

365

Archived records

2

Device classes

2015

Earliest approval

2025

Latest approval

Company overview

Archived records: 365
Province/Region: Guangdong
Address: No. 8, Lizhishan Road, Science City, Luogang District, Guangzhou

Registration timeline

Earliest approval: Sep 15, 2015
Latest approval: Jan 10, 2025

Regulatory footprint

Search Guangzhou Wondfo BIOTECH Co., Ltd. across other regulatory registries

Device class distribution

Breakdown of 365 devices by regulatory classification

Class II29781.4% of total

Class III6818.6% of total

Archived records (10 most recent shown)

Click on any device for detailed registration information

甲型肝炎病毒IgM抗体检测试剂（免疫层析法）

Registration number: 国械注准20253400092
Class: Class III
Expiry date: Jan 09, 2030

Progesterone detection reagent kit (chemiluminescence immunoassay method)

孕酮测定试剂盒（化学发光免疫分析法）

Registration number: 粤械注准20252400018
Class: Class II
Expiry date: Jan 05, 2030

Estradiol determination reagent kit (chemiluminescence immunoassay)

雌二醇测定试剂盒（化学发光免疫分析法）

Registration number: 粤械注准20252400019
Class: Class II
Expiry date: Jan 05, 2030

Serum Amyloid A (SAA) Quality Control

血清淀粉样蛋白A（SAA）质控品

Registration number: 粤械注准20242401690
Class: Class II
Expiry date: Dec 18, 2029

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

Registration number: 粤械注准20242401689
Class: Class II
Expiry date: Dec 18, 2029

C-reactive Protein (CRP) Quality Control Material

C反应蛋白（CRP）质控品

Registration number: 粤械注准20242401691
Class: Class II
Expiry date: Dec 18, 2029

B-type Natriuretic Peptide (BNP) Quality Control

B型钠尿肽（BNP）质控品

Registration number: 粤械注准20242401696
Class: Class II
Expiry date: Dec 18, 2029

Testosterone assay kit (chemiluminescent immunoassay method)

睾酮测定试剂盒（化学发光免疫分析法）

Registration number: 粤械注准20242401619
Class: Class II
Expiry date: Dec 04, 2029

D-dimer (D-Dimer) controls

D-二聚体（D-Dimer）质控品

Registration number: 粤械注准20242401605
Class: Class II
Expiry date: Dec 01, 2029

Interleukin-6 (IL-6) Quality Control

白介素-6（IL-6）质控品

Registration number: 粤械注准20242401606
Class: Class II
Expiry date: Dec 01, 2029

Search the static archive →

About this profile

This static archive contains 365 records under the historical name Guangzhou Wondfo BIOTECH Co., Ltd.. It does not establish the company's complete current portfolio or current authorization status.

Historical English translations and official Chinese names can differ. These archived names are not automatically equated with a holder in the current domestic-registration listing.