Fully automated urine formed component analyzer
- Device class
- Class II
- Model specifications
- UD-2300、UD-2310、UD-2330
- Approval department
- Guangxi Zhuang Autonomous Region Drug Administration广西壮族自治区药品监督管理局
- Registration number
- 桂械注准20242220409
- Approval date
- December 09, 2024
- Expiry date
- December 08, 2029
- Name
- URIT MEDICAL Electronic Co., Ltd.桂林优利特医疗电子有限公司
- Province/Region
- Guangxi广西
- Address
- No. D-07, Information Industrial Park, Guilin High-tech Zone桂林市高新区信息产业园D-07号
- Production address
- 桂林市高新区信息产业园D-07号
适用于对人体尿液中的有形成分进行定量、定性分析.测量项目中,包括6个定量项目:红细胞、白细胞、上皮细胞、透明管型、病理管型、细菌和9个定性项目:草酸钙结晶、尿酸结晶、磷酸铵镁结晶、非晶形结晶、其它结晶、真菌(酵母菌、镰刀菌)、粘液丝、精子、脂肪滴.
适用于对人体尿液中的有形成分进行定量、定性分析。测量项目中，包括6个定量项目：红细胞、白细胞、上皮细胞、透明管型、病理管型、细菌和9个定性项目：草酸钙结晶、尿酸结晶、磷酸铵镁结晶、非晶形结晶、其它结晶、真菌（酵母菌、镰刀菌）、粘液丝、精子、脂肪滴。
由标本处理模块、液路模块、光学模块、显微拍摄模块及数据处理模块组成.
由标本处理模块、液路模块、光学模块、显微拍摄模块及数据处理模块组成。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Fully automated urine formed component 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 桂械注准20242220409 and owned by URIT MEDICAL Electronic Co., Ltd.. The device was approved on December 09, 2024.
This page provides complete registration details including registrant information, province location (Guangxi), 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.