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质谱分析校准品(N) - NMPA Registration 豫械注准20252400027

Access comprehensive regulatory information for 质谱分析校准品(N) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 豫械注准20252400027 and owned by Autobio Diagnostics Co., Ltd.. The device was approved on January 10, 2025.

This page provides complete registration details including registrant information, province location (Henan), 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.

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Class II
豫械注准20252400027
质谱分析校准品(N)
NMPA Registration Number: 豫械注准20252400027
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Intended Use
English

用于安图实验仪器(郑州)有限公司生产的飞行时间质谱检测系统核酸鉴定前仪器的校准。

Device Classification
Device Class
Class II
Model Specifications
80 tests/box
80测试/盒
Approval Department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration Information
Registration Number
豫械注准20252400027
Approval Date
January 10, 2025
Expiry Date
January 09, 2030
Registrant
Name
Autobio Diagnostics Co., Ltd.
郑州安图生物工程股份有限公司
Province/Region
Henan
河南
Address
No. 87, Jingbei 1st Road, Zhengzhou Economic and Technological Development Zone
郑州经济技术开发区经北一路87号
Production Facility
Production Address
郑州经济技术开发区经开第十五大街199号
Structure and Composition
English

由质谱分析校准品(N)(含特定序列的碱基片段)组成。

Storage Conditions and Expiration
English

Store at -20°C and below with a validity period of 9 months.

中文

-20℃及以下储存,有效期9个月。

Additional Information
Appendix
产品技术要求、说明书