Real-time PCR analyzer - NMPA Registration 国械注准20243220529
Access comprehensive regulatory information for Real-time PCR analyzer in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243220529 and owned by Beijing Lepu Medical Technology Co., Ltd.. The device was approved on March 19, 2024.
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.
The product is based on the principle of polymerase chain reaction (PCR) and real-time fluorescence monitoring technology, and is used together with supporting detection reagents to perform qualitative and quantitative detection or melting curve detection of target nucleic acid (DNA/RNA) derived from human samples in clinical practice, including pathogens and human gene projects.
该产品基于聚合酶链式反应原理（PCR）和实时荧光监测技术，与配套的检测试剂共同使用，在临床上对来源于人体样本中的靶核酸（DNA/RNA）进行定性、定量检测或者熔解曲线检测，包括病原体和人类基因项目。
It is composed of a host, a power cord and software (release version number: V1), wherein the host is composed of a support assembly, a temperature control assembly, an optical detection assembly, and a hot cover assembly.
由主机、电源线和软件（发布版本号：V1）组成，其中主机由支撑组件、控温组件、光学检测组件、热盖组件组成。