Pure Global

Baby incubator - NMPA Registration 国械注准20253080100

Access comprehensive regulatory information for Baby incubator 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20253080100 and owned by Shenzhen Comen Medical Instruments Co., Ltd.. The device was approved on January 10, 2025.

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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class III
国械注准20253080100
Baby incubator
婴儿培养箱
NMPA Registration Number: 国械注准20253080100
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

产品用于医疗机构中为婴儿患者提供温湿度适宜的培养治疗环境,可用于对患者的心电、无创血压、有创血压、脉搏血氧饱和度、脉率、呼末二氧化碳、体温、呼吸进行监测。

Device Classification
Device Class
Class III
Model Specifications
B10、B10A、B10B、B10C
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20253080100
Approval Date
January 10, 2025
Expiry Date
January 09, 2030
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
A10-11 floors, 12C, 2 buildings, 1-5 floors, Building 1, FIYTA Watch Building, South Ring Avenue, Mashantou Community, Matian Street, Guangming District, Shenzhen
深圳市光明区马田街道马山头社区南环大道飞亚达钟表大厦1栋A10层-11层、12C,2栋1-5层(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楼、4楼北侧
Structure and Composition
English

婴儿培养箱由主机、功能模块及附件组成。详见附录。

Additional Information
Appendix
产品技术要求