China NMPA legacy archive 粤械注准20232221291Fully automated erythrocyte osmotic fragility analyzer
- Device class
- Class II
- Model specifications
- RA-800、RA-800Plus
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20232221291
- Approval date
- August 02, 2023
- Expiry date
- August 01, 2028
- Province/Region
- Guangdong
- 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).
- 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
This static archive preserves historical registration fields and translations for Fully automated erythrocyte osmotic fragility analyzer, registration 粤械注准20232221291. It does not establish current authorization or complete current product details.
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