Fully automatic glycosylated hemoglobin analyzer - NMPA Registration 鲁械注准20242220826
Access comprehensive regulatory information for Fully automatic glycosylated hemoglobin 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 鲁械注准20242220826 and owned by Shinva Medical Instrument Co., Ltd.. The device was approved on August 23, 2024.
This page provides complete registration details including registrant information, province location (Shandong), 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.
Based on high performance liquid chromatography, it is used in conjunction with the eluent for glycosylated hemoglobin analysis (high performance liquid chromatography) and glycosylated hemoglobin hemolytic agent (high performance liquid chromatography) produced by Xinhua Medical to determine the content of glycosylated hemoglobin in human whole blood samples.
基于高效液相色谱法与新华医疗生产的糖化血红蛋白分析用洗脱液（高效液相色谱法）和糖化血红蛋白溶血剂（高效液相色谱法）配套使用，用于测定人体全血样本中糖化血红蛋白的含量。
The automatic glycosylated hemoglobin analyzer is mainly composed of a sampling system, a liquid chromatography separation system, a colorimetric detection and control system, a display printing system, and software (software type: embedded, release version: 1.0).
全自动糖化血红蛋白分析仪主要由进样系统、液相色谱分离系统、比色检测与控制系统，显示打印系统，软件（软件类型：嵌入式，发布版本：1.0）组成。