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Carbon Dioxide Incubator - NMPA Registration 鲁械注准20252220066

Access comprehensive regulatory information for Carbon Dioxide Incubator in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20252220066 and owned by Shinva Medical Instrument Co., Ltd.. The device was approved on February 02, 2025.

This page provides complete registration details including registrant information, province location (Shandong), 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
鲁械注准20252220066
Carbon Dioxide Incubator
二氧化碳培养箱
NMPA Registration Number: 鲁械注准20252220066
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Pricing
Intended Use
English

对人体来源样本进行体外培养。

Device Classification
Device Class
Class II
Model Specifications
BCC-110GS、BCC-110G、BCC-170GS、BCC-170G、BCC-260GS、BCC-260G。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20252220066
Approval Date
February 02, 2025
Expiry Date
February 01, 2030
Registrant
Name
Shinva Medical Instrument Co., Ltd.
山东新华医疗器械股份有限公司
Province/Region
Shandong
山东
Address
Xinhua Medical Science and Technology Park, Zibo High-tech Industrial Development Zone, Shandong Province
山东省淄博市高新技术产业开发区新华医疗科技园
Production Facility
Production Address
淄博市周村区新华大道2009号
Structure and Composition
English

该产品由温度控制系统、气体浓度控制系统、湿度控制系统、电子显示系统、围护结构、内门加热系统、污染物控制系统以及附件、软件(软件类型:内嵌型)组成。

Additional Information
Appendix
产品技术要求