Fully automated erythrocyte osmotic fragility analyzer
- Device class
- Class II
- Model specifications
- RA-800、RA-800Plus
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20232221291
- Approval date
- August 02, 2023
- Expiry date
- August 01, 2028
- Name
- Shenzhen Lifotronic Technology Co., Ltd.深圳普门科技股份有限公司
- Province/Region
- Guangdong广东
- Address
- 1st floor, Jindi Tianyue Bay, No. 8 Qizhi East Road, Guancheng Community, Guanhu Street, Longhua District, Shenzhen (intersection of Meiguan Expressway and Huanguan South Road).深圳市龙华区观湖街道观城社区求知东路8号金地天悦湾（梅关高速与环观南路交汇处）1层
- Production address
- 广东省东莞市松山湖园区彰化路2号1号厂房4-9楼、11楼
It is used in medical clinics to quantitatively measure the osmotic fragility of red blood cells in human blood in vitro.
在医学临床上用于体外定量测量人体血液中的红细胞渗透脆性。
It consists of a main unit, a power adapter, a barcode scanner, a liquid sensor cable, and software, including a sample injection system, an analysis system, a sample tray (RA-800Plus only), a printer, and a display.
主要由主机、电源适配器、条码扫描枪、液体传感器连接线和软件组成；其中主机包含进样系统、分析系统、样本盘（仅适用于RA-800Plus）、打印机、显示屏。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Fully automated erythrocyte osmotic fragility 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 粤械注准20232221291 and owned by Shenzhen Lifotronic Technology Co., Ltd.. The device was approved on August 02, 2023.
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.