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Fully automated urine formed component analyzer - NMPA Registration 桂械注准20242220409

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.

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NMPA Official Data
Class II
桂械注准20242220409
Fully automated urine formed component analyzer
全自动尿液有形成分分析仪
NMPA Registration Number: 桂械注准20242220409
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DJ Fang

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Pricing
Intended Use
English

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.

中文

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。

Device Classification
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 Information
Registration Number
桂械注准20242220409
Approval Date
December 09, 2024
Expiry Date
December 08, 2029
Registrant
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 Facility
Production Address
桂林市高新区信息产业园D-07号
Structure and Composition
English

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.

中文

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。

Additional Information
Appendix
产品技术要求