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Syringe pump - NMPA Registration 国械注准20243141430

Access comprehensive regulatory information for Syringe pump in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243141430 and owned by Shenzhen Comen Medical Instruments Co., Ltd.. The device was approved on August 05, 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 III
国械注准20243141430
Syringe pump
注射泵
NMPA Registration Number: 国械注准20243141430
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Intended Use
English

This product is used in combination with a companion syringe for clinical use to control the flow of fluid injected into the patient's body, and is suitable for adult, pediatric and neonatal patients, where the patient-controlled analgesia (PCA) mode is only available for adults.

中文

该产品与配套使用注射器联合使用,临床用于控制注入患者体内液体流量,适用于成人、小儿和新生儿患者,其中患者自控镇痛(PCA)模式仅适用于成人。

Device Classification
Device Class
Class III
Model Specifications
M800-L、M800A-L
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243141430
Approval Date
August 05, 2024
Expiry Date
August 04, 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
Shenzhen Guangming District Matian Street Mashantou Community Clock Base Feiyada Watch Building 2 Building 101 (one license multi-address enterprise)
深圳市光明区马田街道马山头社区钟表基地飞亚达钟表大厦2栋101(一照多址企业)
Production Facility
Production Address
深圳市光明区马田街道南环大道飞亚达钟表大厦 2栋 1-5 层;深圳市光明区马田街道富利南路与芳园路交汇处瑞辉大厦 3、 4楼北侧;深圳市光明街道高新西路 11 号研祥科技工业园机械厂房(创祥地 2 号)五楼西侧单元 501
Structure and Composition
English

The product is composed of a pump shell, a motor drive module, an input module, a storage module, a control module, a display module, a sensor monitoring module, an alarm module and accessories (power cord, PCA patient self-controlled anesthesia, fastening clip).

中文

该产品由泵外壳、电机驱动模块、输入模块、存储模块、控制模块、显示模块、传感监测模块、报警模块及附件(电源线、PCA病人自控麻醉、紧固夹)组成。

Additional Information
Appendix
产品技术要求