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Infusion of central information management software - NMPA Registration 粤械注准20242211356

Access comprehensive regulatory information for Infusion of central information management software 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20242211356 and owned by Shenzhen Comen Medical Instruments Co., Ltd.. The device was approved on October 14, 2024.

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.

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NMPA Official Data
Class II
粤械注准20242211356
Infusion of central information management software
输注中央信息管理软件
NMPA Registration Number: 粤械注准20242211356
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Intended Use
English

It is used in conjunction with specific infusion pumps, syringe pumps, and infusion information collection systems to centrally display, alarm, and manage infusion pumps, syringe pumps, and infusion information collection systems. It is not used for infusion monitoring management of analgesics, chemotherapy drugs, or insulin.

中文

与特定的输液泵、注射泵、输液信息采集系统配合使用,对输液泵、注射泵、输液信息采集系统进行集中显示、报警和管理。不用于镇痛药、化疗药物、胰岛素的输注监护管理。

Device Classification
Device Class
Class II
Model Specifications
eCenter-IMS,软件发布版本:1
eCenter-IMS,软件发布版本:1
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242211356
Approval Date
October 14, 2024
Expiry Date
October 13, 2029
Registrant
Name
Shenzhen Comen Medical Instruments Co., Ltd.
深圳市科曼医疗设备有限公司
Province/Region
Guangdong
广东
Address
A10-11 floors, 12C, 2 buildings, 1-5 floors, Building 1, FIYTA Watch Building, South Ring Avenue, Mashantou Community, Matian Street, Guangming District, Shenzhen
深圳市光明区马田街道马山头社区南环大道飞亚达钟表大厦1栋A10层-11层、12C,2栋1-5层(一照多址企业)
Production Facility
Production Address
深圳市光明区马田街道马山头社区钟表基地君斯达科技园D栋第3层和第4层
Structure and Composition
English

It is composed of a monitoring module, a data review module, a data receiving module, a data storage and management module, and a data interface service. The product is delivered via USB stick.

中文

由监护模块、数据回顾模块、数据接收模块、数据存储与管理模块、数据接口服务组成。产品通过 U 盘交付。

Additional Information
Appendix
产品技术要求