Fully automatic biochemical analyzer - NMPA Registration 皖械注准20232220096
Access comprehensive regulatory information for Fully automatic biochemical analyzer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 皖械注准20232220096 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on May 31, 2023.
This page provides complete registration details including registrant information, province location (Anhui), 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.
This series of products is used in conjunction with suitable reagents with valid medical device registration certificates for medical institutions to conduct routine clinical biochemical tests and electrolyte (potassium, sodium, chloride) tests on human serum, cerebrospinal fluid and urine samples.
该系列产品与具有有效医疗器械注册证且适宜的试剂配合使用，供医疗机构用于对人体的血清、脑脊液、尿液样本进行常规临床生化检验及电解质（钾、钠、氯离子）检验使用。
It is composed of host, software component (software version number: V1), electrolyte measurement system (optional: potassium ion, sodium ion, chloride ion), computer part (optional), external printer (optional). The host includes sample system, sample transfer device (sample feeder), reagent system, reaction system, optical system, stirring system, cleaning system, flow path system, electrical control system.
由主机、软件组件（软件版本号：V1）、电解质测量系统（选配：钾离子、钠离子、氯离子）、计算机部分（选配）、外接打印机 (选配)组成。其中主机包括样本系统、样本转移装置（送样器）、试剂系统、反应系统、光学系统、搅拌系统、清洗系统、流路系统、电气控制系统。