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China NMPA legacy archive 国械注准20243141430

Syringe pump

注射泵
Shenzhen Comen Medical Instruments Co., Ltd.Class IIINMPAApproved August 05, 2024
Static archiveNMPA · legacy registration snapshot
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
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。

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
About this record

This static archive preserves historical registration fields and translations for Syringe pump, registration 国械注准20243141430. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.