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Fluorescence immunochromatography analyzer - NMPA Registration 京械注准20232220305

Access comprehensive regulatory information for Fluorescence immunochromatography analyzer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20232220305 and owned by Beijing Tigsun Diagnostics Co., Ltd.. The device was approved on May 08, 2023.

This page provides complete registration details including registrant information, province location (Beijing), 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
京械注准20232220305
Fluorescence immunochromatography analyzer
荧光免疫层析分析仪
NMPA Registration Number: 京械注准20232220305
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Intended Use
English

Used in conjunction with fluorescent bead-labeled fluorescent immunochromatography reagents for in vitro quantitative detection of analytes in human samples.

中文

与荧光微球标记的荧光免疫层析试剂配套使用,用于对人体样本中的待测物进行体外定量检测。

Device Classification
Device Class
Class II
Model Specifications
Tigsun-600
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20232220305
Approval Date
May 08, 2023
Expiry Date
May 07, 2028
Registrant
Name
Beijing Tigsun Diagnostics Co., Ltd.
北京泰格科信生物科技有限公司
Province/Region
Beijing
北京
Address
Building 1, No. 16, District 1, Guba Road, Chengguan Street, Fangshan District, Beijing
北京市房山区城关街道顾八路一区16号1幢
Production Facility
Production Address
北京市房山区城关街道顾八路一区16号1幢
Structure and Composition
English

The analyzer is composed of host (including photoelectric detection module, scanning module, data processing module, liquid crystal display module, thermal printer, shell, etc.), information collection module, random software (release version number: 1), and power adapter.

中文

分析仪由主机(包括光电检测模块、扫描模块、数据处理模块、液晶显示模块、热敏打印机、外壳等)、信息采集模块、随机软件(发布版本号:1)、电源适配器组成。

Storage Conditions and Expiration
English

5 years

中文

5年

Additional Information
Appendix
产品技术要求