Time-of-flight mass spectrometry detection system
- Device class
- Class II
- Model specifications
- DR GeneMass
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20242221066
- Approval date
- August 15, 2024
- Expiry date
- August 14, 2029
- Name
- Guangzhou Darui Biotechnology Co., Ltd.广州市达瑞生物技术股份有限公司
- Province/Region
- Guangdong广东
- Address
- No. 6 Lizhishan Road, Guangzhou High-tech Industrial Development Zone, No. 2 No. 404广州市高新技术产业开发区荔枝山路6号自编2号404
- Production address
- 广州市黄埔区科丰路33号2栋401号01房、02房、03房、05房、13房（委托生产）
By measuring the molecular weight of known nucleic acid fragments, nucleic acid samples derived from humans can be analyzed.
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 composed of a high-voltage control system, a quality analysis system, a laser control system, a vacuum system, an ion source, a motion control system and random software (release version: V1).
由高压控制系统、质量分析系统、激光控制系统、真空系统、离子源、运动控制系统及随机软件（发布版本：V1）组成。
- Remark
- 受托生产企业名称：广州市达安医疗器械有限公司；统一社会信用代码：91440116MA59ANKD5Q。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Time-of-flight mass spectrometry detection 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 粤械注准20242221066 and owned by Guangzhou Darui Biotechnology Co., Ltd.. The device was approved on August 15, 2024.
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.