Pure Global

甲型肝炎病毒IgM抗体检测试剂(免疫层析法) - NMPA Registration 国械注准20253400092

Access comprehensive regulatory information for 甲型肝炎病毒IgM抗体检测试剂(免疫层析法) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253400092 and owned by Guangzhou Wondfo BIOTECH Co., Ltd.. The device was approved on January 10, 2025.

This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class III
国械注准20253400092
甲型肝炎病毒IgM抗体检测试剂(免疫层析法)
NMPA Registration Number: 国械注准20253400092
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

本试剂用于体外定性检测人血清或血浆中的甲型肝炎病毒IgM抗体。

Device Classification
Device Class
Class III
Model Specifications
Card type: foil bag single serving, 1 person/bag, 1 person/box, 10 people/box, 20 people/box, 25 people/box, 40 people/box, 50 people/box.
卡型:铝箔袋单人份包装,1人份/袋、1人份/盒、10人份/盒、20人份/盒、25人份/盒、40人份/盒、50人份/盒。
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20253400092
Approval Date
January 10, 2025
Expiry Date
January 09, 2030
Registrant
Name
Guangzhou Wondfo BIOTECH Co., Ltd.
广州万孚生物技术股份有限公司
Province/Region
Guangdong
广东
Address
No. 8, Lizhishan Road, Science City, Huangpu District, Guangzhou
广州市黄埔区科学城荔枝山路8号
Production Facility
Production Address
广州市黄埔区科学城荔枝山路8号
Structure and Composition
English

测试卡、样本稀释液(滴瓶)、吸管。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

Store at 2~30°C, valid for 24 months.

中文

2~30℃保存,有效期24个月。

Additional Information
Appendix
产品技术要求、说明书