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China NMPA legacy archive 粤械注准20242221066

Time-of-flight mass spectrometry detection system

飞行时间质谱检测系统
Guangzhou Darui Biotechnology Co., Ltd.Class IINMPAApproved August 15, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
粤械注准20242221066
Approval date
August 15, 2024
Expiry date
August 14, 2029
Registrant
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 facility
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)
Intended use
English

By measuring the molecular weight of known nucleic acid fragments, nucleic acid samples derived from humans can be analyzed.

中文

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。

Structure and composition
English

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).

中文

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。

Additional information
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
About this record

This static archive preserves historical registration fields and translations for Time-of-flight mass spectrometry detection system, registration 粤械注准20242221066. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.