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Patient monitors - NMPA Registration 国械注准20243071294

Access comprehensive regulatory information for Patient monitors 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20243071294 and owned by Edan Instruments, Inc.. The device was approved on July 23, 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20243071294
Patient monitors
病人监护仪
NMPA Registration Number: 国械注准20243071294
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Pricing
Intended Use
English

The product is used to perform ECG, respiration (RESP), body temperature (TEMP), pulse oximetry (SpO2), pulse rate (PR), respiration rate (RR) (for adults and pediatrics only), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (CNBP) (for adults and pediatrics only), invasive blood pressure (IBP), Cardiac output (C.O.) (for adults only), carbon dioxide (CO2), anesthetic gas (AG), bispectral index (BIS) (for adults and children only), neuromuscular conduction (NMT) (for adults and children only), respiratory mechanics (RM), electroencephalography (EEG), non-invasive cardiac output (ICG) (for adults only), brain and regional oxygen saturation (rSO2), invasive continuous cardiac output (CCO) (for adults and children only) monitoring, Guardianship information can be displayed, reviewed, stored, and printed. This product should be used in healthcare facilities by professionally trained clinical healthcare professionals.

中文

产品用于对患者进行心电(ECG),呼吸(RESP),体温(TEMP),脉搏血氧饱和度(SpO2),脉率(PR),呼吸率(RR)(仅适用于成人和小儿),无创血压(NIBP),连续无创血压(CNBP)(仅适用于成人和小儿),有创血压(IBP),心输出量(C.O.)(仅适用于成人),二氧化碳(CO2),麻醉气体(AG),脑电双频指数(BIS)(仅适用于成人和小儿),神经肌肉传导(NMT)(仅适用于成人和小儿),呼吸力学(RM),脑电(EEG)、无创心输出量(ICG)(仅适用于成人)、脑部与区域血氧饱和度(rSO2)、有创连续心输出量(CCO) (仅适用于成人和小儿)监护,可以显示、回顾、存储和打印监护信息。该产品应由经过专业培训的临床医护人员在医疗机构中使用。

Device Classification
Device Class
Class III
Model Specifications
iV12,iV1206,iV1208,iV1205,iV1209,iV12A,iV12B,iV12C,iV15,iV1506,iV1508,iV1505,iV1509,iV15A,iV15B,iV15C,iV17,iV1706,iV1708,iV1705,iV1709,iV17A,iV17B,iV17C
iV12,iV1206,iV1208,iV1205,iV1209,iV12A,iV12B,iV12C,iV15,iV1506,iV1508,iV1505,iV1509,iV15A,iV15B,iV15C,iV17,iV1706,iV1708,iV1705,iV1709,iV17A,iV17B,iV17C
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243071294
Approval Date
July 23, 2024
Expiry Date
July 22, 2029
Registrant
Name
Edan Instruments, Inc.
深圳市理邦精密仪器股份有限公司
Province/Region
Guangdong
广东
Address
No. 15, Jinhui Road, Jinsha Community, Kengzi Street, Pingshan New District, Shenzhen
深圳市坪山新区坑梓街道金沙社区金辉路15号
Production Facility
Production Address
深圳市坪山新区坑梓街道金沙社区金辉路15号
Structure and Composition
English

The product is composed of the main engine, battery, plug-in module, auxiliary box and corresponding supporting accessories, see the product structure and composition of the attached page for details.

中文

产品由主机、电池、插件模块、辅箱及相应配套附件组成,详见产品结构及组成附页。

Additional Information
Appendix
产品技术要求