Pure Global

Fully Automatic Reproductive Tract Secretion Analysis System - NMPA Registration 京械注准20232220306

Access comprehensive regulatory information for Fully Automatic Reproductive Tract Secretion Analysis System 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20232220306 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
京械注准20232220306
Fully Automatic Reproductive Tract Secretion Analysis System
全自动生殖道分泌物分析系统
NMPA Registration Number: 京械注准20232220306
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

Microscopic imaging scanning method was used in conjunction with latex chromatography detection reagents to qualitatively and quantitatively analyze the analytes and formed components in human genital tract secretion samples.

中文

采用显微影像扫描法,与乳胶层析法检测试剂配套使用,对人体生殖道分泌物样本中被测物及有形成分进行定性、定量分析。

Device Classification
Device Class
Class II
Model Specifications
Rinpo-1000 pro max
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20232220306
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

This product is composed of a host and random software (release number: 1), of which the host is composed of a sample transfer module, a sampling and cleaning module, a reagent card module, and a microscopic camera module.

中文

本产品由主机和随机软件(发布版本号:1)组成,其中主机由样品传送模块、吸样与清洗模块、试剂卡进卡模块、显微摄像模块组成。

Storage Conditions and Expiration
English

5 years

中文

5年

Additional Information
Appendix
产品技术要求