Time-of-Flight Mass Spectrometry System
- Device class
- Class II
- Model specifications
- EXS 8000
- Approval department
- Chongqing Municipal Drug Administration重庆市药品监督管理局
- Registration number
- 渝械注准20242220413
- Approval date
- October 17, 2024
- Expiry date
- October 16, 2029
- Name
- Zybio Inc.中元汇吉生物技术股份有限公司
- Province/Region
- Chongqing重庆
- Address
- Floor 1-4, Building 30, No. 6 Taikang Road, Area C, Jianqiao Industrial Park, Dadukou District, Chongqing重庆市大渡口区建桥工业园C区太康路6号30栋第1-4层
- Production address
- 重庆市大渡口区建桥工业园C区太康路6号30栋第1-4层、5层A区；重庆市大渡口跳磴镇海兴路333号建桥生物医药园附3号第1-5层、附4号第1-5层；重庆市大渡口区建桥工业园C区太康路3号24-25栋2层A区
The product is based on matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) technology, which can analyze nucleic acid samples from human bodies by detecting the molecular weight of known nucleic acid fragments.
产品基于基质辅助激光解吸电离飞行时间质谱（MALDI-TOF MS）技术，通过检测已知核酸片段分子量，可对来源于人体的核酸样本进行分析。
It is mainly composed of a host, software and a target holder. The main machine is composed of an ion detector, a vacuum system, a mass analyzer, an ion source, a laser, an XY mobile platform, a target camera and a high-voltage pulse box power supply system. The software includes time-of-flight mass spectrometry system acquisition software (release version: V1) and time-of-flight mass spectrometry system gene analysis software (release version: V1), and the software is a control software component.
主要由主机、软件及靶托组成。其中主机由离子探测器、真空系统、质量分析器、离子源、激光器、XY移动平台、靶点摄像以及高压脉冲盒电源系统组成；其中软件包括飞行时间质谱系统采集软件（发布版本：V1）和飞行时间质谱系统基因分析软件（发布版本：V1），软件为控制型软件组件。
- Remark
- 首次注册。
Access comprehensive regulatory information for Time-of-Flight Mass Spectrometry 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 渝械注准20242220413 and owned by Zybio Inc.. The device was approved on October 17, 2024.
This page provides complete registration details including registrant information, province location (Chongqing), 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.