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Carbon Monoxide Detector - NMPA Registration 京械注准20252070051

Access comprehensive regulatory information for Carbon Monoxide Detector in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20252070051 and owned by Beijing SenMeiXiKeMa Biotechnology Co., Ltd.. The device was approved on January 25, 2025.

This page provides complete registration details including registrant information, province location (Beijing), 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
京械注准20252070051
Carbon Monoxide Detector
一氧化碳检测器
NMPA Registration Number: 京械注准20252070051
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Intended Use
English

本产品配套公司I2C接口的呼气分析仪使用,用于检测呼出气中一氧化碳浓度。

Device Classification
Device Class
Class II
Model Specifications
ECmode-NC-C100,ECmode-NC-C300,ECmode-NC-C500,ECmode-NC-C800,ECmode-NC-C1000,ECmode-NC-C1500,ECmode-NC-C2000
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20252070051
Approval Date
January 25, 2025
Expiry Date
January 24, 2030
Registrant
Name
Beijing SenMeiXiKeMa Biotechnology Co., Ltd.
北京森美希克玛生物科技有限公司
Province/Region
Beijing
北京
Address
4th Floor, Building 1, Yard 85, Kechuang 6th Street, Beijing Economic and Technological Development Zone, Beijing (Yizhuang Group, High-end Industrial Area, Beijing Pilot Free Trade Zone)
北京市北京经济技术开发区科创六街85号院1号楼4层(北京自贸试验区高端产业片区亦庄组团)
Production Facility
Production Address
北京市北京经济技术开发区科创六街85号院1号楼4层
Structure and Composition
English

It consists of housing, hardware interface card, carbon monoxide sensor.

中文

由外壳、硬件接口卡、一氧化碳传感器组成。

Storage Conditions and Expiration
English

2 years

中文

2年

Additional Information
Appendix
产品技术要求